G2 FILTER
Report
- Report Number
- 2020394-2019-01920
- Event Type
- Malfunction
- Date Received
- July 25, 2019
- Report Date
- April 20, 2022
- Manufacturer
- BARD PERIPHERAL VASCULAR, INC.
- Product Code
- DTK
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
OF THE REPORTED 42 MALFUNCTIONS, 7 WERE REASSESSED FOR REPORTABILITY AND DETERMINED TO BE REPORTABLE AS A SERIOUS INJURY, AND WERE REPORTED UNDER EMDRS 2020394-2020-06404, 2020394-2020-06442, 2020394-2019-04489, 2020394-2019-04421, 2020394-2020-06440, 2020394-2019-04530 AND 2020394-2021-80264. OF THE REPORTED 35 MALFUNCTIONS, FOR FOUR MALFUNCTIONS THE CATALOG NUMBER WAS UPDATED RF320J, FOR TWO MALFUNCTIONS THE CATALOG NUMBER WAS UPDATED RF400F AND FOR TWO MALFUNCTIONS THE CATALOG NUMBER WAS UPDATED UNKNOWN G2. OF THE REPORTED 35 MALFUNCTIONS, LOT NUMBER WERE PROVIDED FOR 21 MALFUNCTIONS AND THE LOT HISTORY REVIEW WERE PERFORMED. THE SAMPLES WERE NOT RETURNED TO THE MANUFACTURER FOR INSPECTION/EVALUATION. HOWEVER; MEDICAL RECORDS WERE RECEIVED FOR 31 MALFUNCTIONS AND IMAGES WERE PROVIDED FOR 7 MALFUNCTIONS. THEREFOR, 24 MALFUNCTIONS INVESTIGATION IS CONFIRMED FOR PATIENT DEVICE INTERACTION PROBLEM, FOR 6 MALFUNCTIONS INVESTIGATION IS INCONCLUSIVE FOR PATIENT DEVICE INTERACTION PROBLEM, FOR THREE MALFUNCTIONS INVESTIGATION IS CONFIRMED FOR PATIENT DEVICE INTERACTION PROBLEM, ADDITIONALLY IT WAS DETERMINED TO HAVE AND CONFIRMED FOR MALPOSITION OF DEVICE. FOR THE REMAINING TWO MALFUNCTIONS THE COMPANY IS STILL INVESTIGATING THE ISSUE AT THIS TIME. THE DEVICES ARE LABELED FOR SINGLE USE. (CORPORATE LOT: D4 (CORPORATE LOT NUMBER: GFPK1183, GFTG3545, GFSG0227, GFRL1966, GFTJ1623, GFRC0708, GFTK3478, GFUA0285, GFRA0586, GFSL2720, GFRK3181, GFSL2718, GFQJ4840, GFRC2688, GFRH5513, GFRA0587, GFSD2862, GFTH3826, UNKNOWN). THE INFORMATION PROVIDED BY BD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BD.
H10: OF THE REPORTED 42 MALFUNCTIONS, 7 WERE REASSESSED FOR REPORTABILITY AND DETERMINED TO BE REPORTABLE AS A SERIOUS INJURY, AND WERE REPORTED UNDER EMDRS 2020394-2020-06404, 2020394-2020-06442, 2020394-2019-04489, 2020394-2019-04421, 2020394-2020-06440, 2020394-2019-04530 AND 2020394-2021-80264. H10: OF THE REPORTED 35 MALFUNCTIONS, FOR FOUR MALFUNCTIONS THE CATALOG NUMBER WAS UPDATED RF320J, FOR TWO MALFUNCTIONS THE CATALOG NUMBER WAS UPDATED RF400F AND FOR ONE MALFUNCTION THE CATALOG NUMBER WAS UPDATED UNKNOWN G2. H10: OF THE REPORTED 35 MALFUNCTIONS, LOT NUMBER WERE PROVIDED FOR 22 MALFUNCTIONS AND THE LOT HISTORY REVIEW WERE PERFORMED. THE SAMPLES WERE NOT RETURNED TO THE MANUFACTURER FOR INSPECTION/EVALUATION. HOWEVER; MEDICAL RECORDS WERE RECEIVED FOR 33 MALFUNCTIONS AND IMAGES WERE PROVIDED FOR 9 MALFUNCTIONS. THEREFORE, 26 MALFUNCTIONS INVESTIGATION IS CONFIRMED FOR PATIENT DEVICE INTERACTION PROBLEM, FOR FOUR MALFUNCTIONS INVESTIGATION IS INCONCLUSIVE FOR PATIENT DEVICE INTERACTION PROBLEM, FOR THREE MALFUNCTIONS INVESTIGATION IS CONFIRMED FOR PATIENT DEVICE INTERACTION PROBLEM, ADDITIONALLY IT WAS DETERMINED TO HAVE AND CONFIRMED FOR MALPOSITION OF DEVICE, FOR THE ONE MALFUNCTION INVESTIGATION IS CONFIRMED FOR PATIENT DEVICE INTERACTION PROBLEM, ADDITIONALLY IT WAS DETERMINED TO HAVE DETACHMENT AND MALPOSITION OF DEVICE, AND IT IS CONFIRMED FOR DETACHMENT AND UNCONFIRMED FOR MALPOSITION OF DEVICE(A150202) AND FOR THE REMAINING ONE MALFUNCTION INVESTIGATION IS CONFIRMED FOR PATIENT DEVICE INTERACTION PROBLEM, ADDITIONALLY IT WAS DETERMINED TO HAVE DETACHMENT(A0501), MIGRATION(A0104) AND MALPOSITION OF DEVICE, AND IT IS CONFIRMED FOR DETACHMENT AND MIGRATION, AND IT IS UNCONFIRMED FOR MALPOSITION OF DEVICE. BASED ON THE AVAILABLE INFORMATION, THE DEFINITIVE ROOT CAUSE FOR THIS EVENT IS UNKNOWN. THE DEVICES ARE LABELED FOR SINGLE USE. H10: D4 (CORPORATE LOT: D4 (CORPORATE LOT NUMBER: GFPK1183, GFTG3545, GFSG0227, GFRL1966, GFPK1183, GFRC0708, GFTK3478, GFUA0285, GFRA0586, GFSL2720, GFRK3181, GFSL2718, GFQJ4840, GFRC2688, GFRH5513, GFRA0587, GFSD2862, GFUA4054, GFTH3826, UNKNOWN), G3. H11: B5, H6 (RESULT, CONCLUSION) H11:SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BD.
H10: OF THE REPORTED 42 MALFUNCTIONS, 8 WERE REASSESSED FOR REPORTABILITY AND DETERMINED TO BE REPORTABLE AS A SERIOUS INJURY, AND WERE REPORTED UNDER EMDRS 2020394-2021-80264,2020394-2020-06404,2020394-2020-06442,2020394-2019-04489,2020394-2019-04421,2020394-2020-06440, 2020394-2019-04530 AND 2020394-2021-80737. H10: THE LOT NUMBER WAS PROVIDED FOR 21 OUT OF 34 REPORTED MALFUNCTIONS, THEREFORE, LOT HISTORY REVIEWS WERE PERFORMED. OUT OF 34 REPORTED MALFUNCTIONS, PRODUCT CATALOG NUMBER FOR FOUR MALFUNCTIONS WERE UPDATED AS RF320J, ONE MALFUNCTION WAS UPDATED AS RF400F AND ANOTHER MALFUNCTIONS UPDATED UNKNOWN G2. THE DEVICES WERE NOT RETURNED FOR EVALUATION; HOWEVER, MEDICAL RECORDS WERE PROVIDED AND REVIEWED FOR 33 MALFUNCTIONS OF WHICH 9 INCLUDED IMAGES. MEDICAL RECORD WAS NOT PROVIDED FOR ONE MALFUNCTION, THEREFORE THE INVESTIGATION IS INCONCLUSIVE FOR THE ALLEGED PERFORATION. FOR 26 OF THE 34 REPORTED MALFUNCTIONS, THE INVESTIGATION IS CONFIRMED FOR THE ALLEGED PERFORATION. FOR ONE MALFUNCTION, THE INVESTIGATION IS CONFIRMED FOR THE REPORTED PERFORATION, DETACHMENT AND MIGRATION, THEREFORE, A0501, A10402 TRENDING CODES WERE ADDED ADDITIONALLY; HOWEVER, UNCONFIRMED FOR TILT. THREE MALFUNCTIONS ARE CONFIRMED FOR THE ALLEGED PERFORATION AND TILT, THEREFORE A150202 CODE WAS ADDED. ONE MALFUNCTION IS CONFIRMED FOR PERFORATION AND DETACHMENT; HOWEVER, UNCONFIRMED FOR TILT. THE REMAINING TWO MALFUNCTION IS INCONCLUSIVE FOR THE ALLEGED PERFORATION. BASED ON THE AVAILABLE INFORMATION, THE DEFINITIVE ROOT CAUSE FOR THIS EVENT IS UNKNOWN. THE DEVICES WERE LABELED FOR SINGLE USE. H10: D4 (CORPORATE LOT: D4 (CORPORATE LOT NUMBER: GFPK1183, GFTG3545, GFSG0227, GFRL1966,GFRC0708, GFTK3478, GFUA0285, GFRA0586, GFSL2720, GFRK3181, GFQJ4840, GFRC2688, GFRH5513, GFRA0587, GFSD2862, GFUA4054, GFTH3826, UNKNOWN), G3. H11: B5. H11:SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BD.
H10: OF THE 42 REPORTED MALFUNCTIONS, 3 WERE REASSESSED FOR REPORTABILITY AND DETERMINED TO BE REPORTABLE AS A SERIOUS INJURY, AND WERE REPORTED UNDER EMDRS 2020394-2019-04489, 2020394-2019-04421 AND 2020394-2019-04530. H10: LOT NUMBERS WERE RETURNED FOR 18 MALFUNCTIONS ARE LOT HISTORY REVIEWS WERE PERFORMED. OF THE 39 MALFUNCTIONS, TWO MALFUNCTIONS HAD PRODUCT CATALOG NUMBER UPDATED TO RF320J AND ONE HAD PRODUCT CATALOG NUMBER UPDATED TO RF400F. OF THE TWO MALFUNCTIONS WITH PRODUCT CATALOG NUMBER RF320J, THE DEVICES WERE NOT RETURNED BUT MEDICAL RECORDS WERE RECEIVED; ONE INVESTIGATION WAS REASSESSED TO HAVE EXPERIENCED TILT AND PERFORATION AND IS INCONCLUSIVE. THE OTHER MALFUNCTION WITH RF320J IS CONFIRMED FOR PERFORATION. THE MALFUNCTION WITH PRODUCT CATALOG NUMBER RF400F DID NOT HAVE A SAMPLE RETURNED AND IS INCONCLUSIVE FOR PERFORATION. OF THE REMAINING 36 MALFUNCTIONS, THE DEVICES WERE NOT RETURNED HOWEVER MEDICAL RECORDS WERE RECEIVED FOR 12 MALFUNCTIONS. 11 MALFUNCTIONS ARE CONFIRMED FOR PERFORATION AND 1 MALFUNCTION IS INCONCLUSIVE FOR PERFORATION. ONE MALFUNCTION THAT DID NOT HAVE MEDICAL RECORDS RECEIVED WAS REASSESSED AND DETERMINED TO HAVE EXPERIENCED TILT, DETACHMENT, AND PERFORATION; THIS MALFUNCTION IS INCONCLUSIVE AS NO OBJECTIVE EVIDENCE HAS BEEN PROVIDED TO CONFIRM ANY ALLEGED FAILURE WITH THE DEVICE. THE REMAINING 23 MALFUNCTIONS ARE INCONCLUSIVE FOR PERFORATION AS NO OBJECTIVE EVIDENCE HAS BEEN PROVIDED TO CONFIRM ANY ALLEGED FAILURE WITH THE DEVICE. BASED UPON THE AVAILABLE INFORMATION, THE DEFINITIVE ROOT CAUSE IS UNKNOWN. THE DEVICES ARE LABELED FOR SINGLE USE. H10: G4, D4 (PRODUCT CATALOG NO. RF320J AND CORPORATE LOT NO. GFPK1183, GFRL1966, GFTK3478, GFUA0285, GFRA0586, GFTG3545, GFSG0227, GFRK3181, GFRC2688, GFQJ4840, GFSD1173, GFRC0708, GFSL2718,GFTH3826, UNKNOWN). H11:SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BD.
H10: OF THE 42 REPORTED MALFUNCTIONS, 3 WERE REASSESSED FOR REPORTABILITY AND DETERMINED TO BE REPORTABLE AS A SERIOUS INJURY, AND WERE REPORTED UNDER EMDRS 2020394-2019-04489, 2020394-2019-04421 AND 2020394-2019-04530. H10: LOT NUMBERS WERE RETURNED FOR 22 MALFUNCTIONS AND LOT HISTORY REVIEWS WERE PERFORMED. OF THE 39 MALFUNCTIONS, THREE MALFUNCTIONS HAD PRODUCT CATALOG NUMBER UPDATED TO RF320J AND TWO HAD PRODUCT CATALOG NUMBER UPDATED TO RF400F. OF THE THREE MALFUNCTIONS WITH PRODUCT CATALOG NUMBER RF320J, THE DEVICES WERE NOT RETURNED BUT MEDICAL RECORDS WERE RECEIVED; ONE INVESTIGATION WAS REASSESSED TO HAVE EXPERIENCED TILT AND PERFORATION AND IS INCONCLUSIVE. THE OTHER TWO MALFUNCTIONS WITH RF320J ARE CONFIRMED FOR PERFORATION. OF THE TWO MALFUNCTIONS WITH PRODUCT CATALOG NUMBER RF400J, ONE MALFUNCTION RECEIVED MEDICAL RECORDS AND IS INCONCLUSIVE FOR PERFORATION AND THE OTHER DID NOT RECEIVE MEDICAL RECORDS AND IS INCONCLUSIVE FOR PERFORATION. OF THE REMAINING 34 MALFUNCTIONS, THE DEVICES WERE NOT RETURNED HOWEVER MEDICAL RECORDS WERE RECEIVED FOR 19 MALFUNCTIONS. 14 MALFUNCTIONS ARE CONFIRMED FOR PERFORATION. ONE MALFUNCTION IS CONFIRMED FOR PERFORATION AND TILT. ONE MALFUNCTION IS INCONCLUSIVE FOR PERFORATION. 14 MALFUNCTIONS DID NOT HAVE MEDICAL RECORDS RETURNED AND ARE INCONCLUSIVE FOR PERFORATION AS NO OBJECTIVE EVIDENCE HAS BEEN PROVIDED TO CONFIRM ANY ALLEGED DEFICIENCY WITH THE DEVICE. ONE MALFUNCTION WITHOUT MEDICAL RECORDS WAS REASSESSED AND DETERMINED TO HAVE ALLEGED PERFORATION AND TILT; THIS MALFUNCTION IS INCONCLUSIVE. THREE MALFUNCTIONS HAVE HAD MEDICAL RECORDS PROVIDED AND REVIEW IS CURRENTLY UNDERWAY. H10: D4 (CORPORATE LOT: D4 (CORPORATE LOT NUMBER: GFTG3545, GFSG0227, GFRL1966, GFPK1183, GFRC0708, GFTK3478, GFUA0285, GFSD1173, GFRA0586, GFRK3181, GFQJ4840, GFRC2688, GFQA2792, GFRH5513, GFSD2862, GFTH3826, GFSL2720, GFSL2718, UNKNOWN), G4. H11: B5, H6(DEVICE, METHOD, RESULT). H11:SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BD.
H10: OF THE (B)(4) DEVICES, THE PRODUCT CATALOG NUMBER OF (B)(4) DEVICE WAS UPDATED TO RF400F G2X FILTER. H10: OF THE (B)(4) REPORTED MALFUNCTIONS, (B)(4) WERE REASSESSED FOR REPORTABILITY AND DETERMINED TO BE REPORTABLE AS A SERIOUS INJURY, AND WERE REPORTED UNDER EMDRS 2020394-2019-04489, 2020394-2019-04421 AND 2020394-2019-04530. H10: THE LOT NUMBERS FOR (B)(4) OF THE REMAINING (B)(4) DEVICES WERE PROVIDED AND LOT HISTORY REVIEWS WERE PERFORMED. NONE OF THE DEVICES WERE RETURNED FOR EVALUATION; HOWEVER, MEDICAL RECORDS WERE PROVIDED FOR (B)(4) MALFUNCTIONS. ELEVEN OF THE TWELVE MALFUNCTIONS CONFIRMED FOR PERFORATION, ONE OF WHICH CONTAINED IMAGES, AND ONE MALFUNCTION WAS INCONCLUSIVE FOR THE ISSUE AS NO DEVICE DEFICIENCY WAS PRESENT. THE REMAINING (B)(4) MALFUNCTIONS' INVESTIGATIONS ARE INCONCLUSIVE AS NO OBJECTIVE EVIDENCE WAS PROVIDED FOR REVIEW. ADDITIONALLY, ONE MALFUNCTION WAS REASSESSED AND ADDED FAILURE MODES OF TILT (2616) AND DETACHMENT OF DEVICE (2907) TO TRENDING. THE DEFINITIVE ROOT CAUSE IS UNKNOWN. THE DEVICES ARE LABELED FOR SINGLE USE. H10: G4, D4 CORPORATE LOT NO (GFPK1183, GFRL1966, GFTK3478, GFUA0285, GFRA0586, GFTG3545, GFSG0227, GFRK3181, GFRC2688, GFQJ4840, GFSD1173, GFRC0708, GFSL2718,GFTH3826, GFQJ4824, GFRA1150, UNKNOWN) H11: B5, H6 (RESULTS, CONCLUSION) H11:SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BD.
H10: OF THE 42 DEVICES, THE PRODUCT CATALOG NUMBER OF 1 DEVICE WAS UPDATED TO RF400F G2X FILTER. OF THE 42 REPORTED MALFUNCTIONS, 3 WERE REASSESSED FOR REPORTABILITY AND DETERMINED TO BE REPORTABLE AS A SERIOUS INJURY, AND WERE REPORTED UNDER EMDRS 2020394-2019-04489, 2020394-2019-04421 AND 2020394-2019-04530. THE LOT NUMBERS FOR 18 OF THE REMAINING 39 DEVICES WERE PROVIDED AND LOT HISTORY REVIEWS WERE PERFORMED. NONE OF THE DEVICES WERE RETURNED FOR EVALUATION; HOWEVER, MEDICAL RECORDS WERE PROVIDED FOR 15 MALFUNCTIONS, WITH IMAGES PROVIDED WITH 4 OF THE 15 MEDICAL RECORDS. 12 OF THE 15 MALFUNCTIONS CONFIRMED FOR PERFORATION (4001), 2 OF WHICH CONTAINED IMAGES. ONE MALFUNCTION WITH IMAGES REVIEWED CONFIRMED PERFORATION (4001) AND OCCLUSION (2423). ONE MALFUNCTION WITH IMAGES REVIEWED CONFIRMED PERFORATION (4001) AND WAS INCONCLUSIVE FOR DETACHMENT OF THE DEVICE OR A DEVICE COMPONENT (2919). ONE MALFUNCTION WAS INCONCLUSIVE FOR THE ISSUE AS NO DEVICE DEFICIENCY WAS PRESENT. THE REMAINING 24 MALFUNCTIONS' INVESTIGATIONS ARE INCONCLUSIVE AS NO OBJECTIVE EVIDENCE WAS PROVIDED FOR REVIEW. ADDITIONALLY, 3 MALFUNCTIONS WERE REASSESSED AND TRENDING DEVICE CODES WERE UPDATED: ONE MALFUNCTION ADDED TILT (2616), ONE MALFUNCTION ADDED DETACHMENT OF DEVICE (2907), AND ONE MALFUNCTION ADDED OCCLUSION (2423). THE DEFINITIVE ROOT CAUSE IS UNKNOWN. THE DEVICES ARE LABELED FOR SINGLE USE. H10: G4, D4 CORPORATE LOT NO (GFPK1183, GFRL1966, GFTK3478, GFUA0285, GFRA0586, GFTG3545, GFSG0227, GFRK3181, GFRC2688, GFQJ4840, GFSD1173, GFRC0708, GFSL2718,GFTH3826, GFQJ4824, GFRA1150, UNKNOWN).
H10: OF THE REPORTED 42 MALFUNCTIONS, 9 WERE REASSESSED FOR REPORTABILITY AND DETERMINED TO BE REPORTABLE AS A SERIOUS INJURY, AND WERE REPORTED UNDER EMDRS 2020394-2021-80264,2020394-2021-80737, 2020394-2020-06404,2020394-2020-06442,2020394-2019-04489,2020394-2019-04421,2020394-2020-06440, 2020394-2019-04530 AND 2020394-2022-90148. H10: THE LOT NUMBER WAS PROVIDED FOR 20 OUT OF 33 REPORTED MALFUNCTIONS, THEREFORE, LOT HISTORY REVIEWS WERE PERFORMED. OUT OF 33 REPORTED MALFUNCTIONS, PRODUCT CATALOG NUMBER FOR FOUR MALFUNCTIONS WERE UPDATED AS RF320J, ONE MALFUNCTION WAS UPDATED AS RF400F AND THE REMAINING ONE MALFUNCTION WAS UPDATED AS UNKNOWN G2. THE DEVICES WERE NOT RETURNED FOR EVALUATION; HOWEVER, MEDICAL RECORDS WERE PROVIDED AND REVIEWED FOR 32 MALFUNCTIONS OF WHICH 8 INCLUDED IMAGES. MEDICAL RECORD WAS NOT PROVIDED FOR ONE MALFUNCTION, THEREFORE THE INVESTIGATION IS INCONCLUSIVE FOR THE ALLEGED PERFORATION. FOR 26 OF THE 33 REPORTED MALFUNCTIONS, THE INVESTIGATION IS CONFIRMED FOR THE ALLEGED PERFORATION. FOR ONE MALFUNCTION, THE INVESTIGATION IS CONFIRMED FOR THE REPORTED PERFORATION, DETACHMENT AND MIGRATION, THEREFORE, A0501, A10402 TRENDING CODES WERE ADDED ADDITIONALLY; HOWEVER, UNCONFIRMED FOR TILT. THREE MALFUNCTIONS ARE CONFIRMED FOR THE ALLEGED PERFORATION AND TILT, THEREFORE A150202 CODE WAS ADDED. ONE MALFUNCTION IS CONFIRMED FOR PERFORATION AND DETACHMENT; HOWEVER, UNCONFIRMED FOR TILT. THE REMAINING ONE MALFUNCTION IS INCONCLUSIVE FOR THE ALLEGED PERFORATION. BASED ON THE AVAILABLE INFORMATION, THE DEFINITIVE ROOT CAUSE FOR THIS EVENT IS UNKNOWN. THE DEVICES WERE LABELED FOR SINGLE USE. H10: D4 (CORPORATE LOT: D4 (CORPORATE LOT NUMBER: GFPK1183, GFTG3545, GFSG0227, GFRL1966,GFRC0708, GFTK3478, GFUA0285, GFRA0586, GFSL2720, GFRK3181, GFQJ4840, GFRC2688, GFRH5513, GFRA0587, GFSD2862,GFTH3826, UNKNOWN), G3. H11: B5 H11:SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BD.
H10: OF THE 42 DEVICES, 19 LOT NUMBERS WERE PROVIDED, AND LOT HISTORY REVIEWS WERE PERFORMED. NO DEVICES WERE RETURNED FOR EVALUATION. MEDICAL RECORDS WERE PROVIDED FOR 15 MALFUNCTIONS AND IMAGES WERE PROVIDED FOR THREE MALFUNCTIONS. PERFORATION OF THE IVC WERE CONFIRMED FOR 10 DEVICES. PERFORATION OF THE IVC WERE INCONCLUSIVE FOR 28 DEVICES. 4 MALFUNCTIONS ARE STILL PENDING MEDICAL RECORD AND AN X-RAY IMAGE WAS PROVIDED AND THE COMPANY IS STILL INVESTIGATING THIS ISSUE. A ROOT CAUSE HAS NOT BEEN DETERMINED. THE DEVICES WERE LABELED FOR SINGLE USE.H10: G4, D4 CORPORATE LOT NO (GFPK1183 (2), GFRL1966, GFTK3478, GFUA0285, GFRA0586, GFTG3545, GFSG0227, GFRK3181, GFRC2688, GFQJ4840, GFSD1173, GFRC0708, GFSL2718,GFTH3826, GFQJ4824, UNKNOWN (24))H11: B5H11:SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BD.
H10: OF THE 42 REPORTED MALFUNCTIONS, 6 WERE REASSESSED FOR REPORTABILITY AND DETERMINED TO BE REPORTABLE AS A SERIOUS INJURY, AND WERE REPORTED UNDER EMDRS 2020394-2020-06404, 2020394-2020-06442, 2020394-2019-04489, 2020394-2019-04421, 2020394-2020-06440 AND 2020394-2019-04530. H10: LOT NUMBERS WAS RECEIVED FOR 22 MALFUNCTIONS AND A LOT HISTORY REVIEWS WAS PERFORMED. OF THE 36 MALFUNCTIONS, THREE MALFUNCTIONS HAD PRODUCT CATALOG NUMBER UPDATED TO RF320J AND TWO HAD PRODUCT CATALOG NUMBER UPDATED TO RF400F. OF THE THREE MALFUNCTIONS WITH PRODUCT CATALOG NUMBER RF320J, THE DEVICES WERE NOT RETURNED BUT MEDICAL RECORDS WERE RECEIVED; ONE INVESTIGATION WAS REASSESSED TO HAVE EXPERIENCED TILT AND PERFORATION AND IS INCONCLUSIVE. THE ONE MALFUNCTION WITH RF320J IS CONFIRMED FOR PERFORATION AND TILT, THE LAST MALFUNCTION WITH RF320J IS CONFIRMED FOR PERFORATION. OF THE TWO MALFUNCTIONS WITH PRODUCT CATALOG NUMBER RF400J, ONE MALFUNCTION RECEIVED MEDICAL RECORDS AND IS INCONCLUSIVE FOR PERFORATION AND THE OTHER DID NOT RECEIVE MEDICAL RECORDS AND IS INCONCLUSIVE FOR PERFORATION. FOR THE REMAINING MALFUNCTIONS, THE DEVICES WERE NOT RETURNED HOWEVER MEDICAL RECORDS WERE RECEIVED FOR 23 MALFUNCTIONS. 21 MALFUNCTIONS WERE CONFIRMED FOR PERFORATION. ONE MALFUNCTION IS CONFIRMED FOR PERFORATION AND TILT. ONE MALFUNCTION IS INCONCLUSIVE FOR PERFORATION. ONE MALFUNCTION WAS REEVALUATED TO HAVE CAPTURED PERFORATION, TILT, AND DETACHMENT AND IS INCONCLUSIVE AS MEDICAL RECORDS WERE NOT RECEIVED. 8 MALFUNCTIONS DID NOT HAVE MEDICAL RECORDS RETURNED AND ARE INCONCLUSIVE FOR PERFORATION AS NO OBJECTIVE EVIDENCE HAS BEEN PROVIDED TO CONFIRM ANY ALLEGED DEFICIENCY WITH THE DEVICE. THE DEFINITE ROOT CAUSE COULD NOT BE DETERMINED BASED ON THE AVAILABLE INFORMATION. THE DEVICES ARE LABELED FOR SINGLE USE. H10: D4 (CORPORATE LOT: D4 (CORPORATE LOT NUMBER: GFTG3545, GFSG0227, GFRL1966, GFPK1183, GFRC0708, GFTK3478, GFUA0285, GFSD1173, GFRA0586, GFRK3181, GFQJ4840, GFRC2688, GFRH5513, GFSD2862, GFTH3826, GFSL2720, GFSL2718, GFRA0587, UNKNOWN). H11:SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BD.
THIS REPORT SUMMARIZES 35 MALFUNCTIONS. A REVIEW OF THE REPORTED INFORMATION INDICATES THAT MODEL RF310F VENA CAVA FILTER ALLEGEDLY EXPERIENCED PATIENT DEVICE INTERACTION PROBLEM. THESE INFORMATION'S WERE RECEIVED FROM A VARIOUS SOURCES. ALL 35 MALFUNCTIONS INVOLVED PATIENT WITH NO PATIENT CONSEQUENCES. OF THE 35 PATIENTS, 21 WERE MALE AND 11 WERE FEMALE, 26 PATIENTS AGE RANGED FROM 30-84 YEARS AND FOUR PATIENTS WEIGHS IN THE RANGE BETWEEN 202 - 438 LBS. ALL OTHER PATIENT DETAILS WERE NOT PROVIDED.
THIS REPORT SUMMARIZES 35 MALFUNCTIONS. A REVIEW OF THE REPORTED INFORMATION INDICATES THAT MODEL RF310F VENA CAVA FILTER ALLEGEDLY EXPERIENCED PATIENT DEVICE INTERACTION PROBLEM. THESE INFORMATION'S WERE RECEIVED FROM A VARIOUS SOURCES. ALL 35 MALFUNCTIONS INVOLVED PATIENT WITH NO PATIENT CONSEQUENCES. OF THE 35 PATIENTS, 22 WERE MALE AND 11 WERE FEMALE, 28 PATIENTS AGE RANGED BETWEEN 30-84 YEARS AND FIVE PATIENTS WEIGHS IN THE RANGE BETWEEN 202 - 438 LBS. ALL OTHER PATIENT DETAILS WERE NOT PROVIDED.
THIS REPORT SUMMARIZES 34 MALFUNCTIONS. A REVIEW OF THE REPORTED INFORMATION INDICATES THAT MODEL RF310F VENA CAVA FILTER ALLEGEDLY EXPERIENCED PERFORATION. THESE INFORMATION'S WERE RECEIVED FROM A VARIOUS SOURCES. ALL THE THIRTY FOUR MALFUNCTIONS INVOLVED PATIENT WITH NO PATIENT CONSEQUENCES. OF THE 34 PATIENTS, 22 WERE MALE AND 11 WERE FEMALE, 28 PATIENTS AGE RANGED BETWEEN 30-84 YEARS AND FIVE PATIENTS WEIGHS IN THE RANGE BETWEEN 202 - 438 LBS. ALL OTHER PATIENT DETAILS WERE NOT PROVIDED.
THIS REPORT SUMMARIZES 39 MALFUNCTIONS. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL RF310F VENA CAVA FILTER EXPERIENCED A PATIENT DEVICE INTERACTION PROBLEM. THESE REPORTS WERE RECEIVED FROM VARIOUS SOURCES. THESE MALFUNCTIONS INVOLVED PATIENTS WITH NO PATIENT CONSEQUENCES. TEN PATIENTS RANGED FROM 20-82 YEARS OF AGE. ONE PATIENT WEIGHS 202 LBS. OF THE REPORTED PATIENTS, 9 WERE MALE AND 6 WERE FEMALE. THE REST OF THE PATIENTS' AGE, WEIGHT, AND GENDER WERE NOT PROVIDED.
THIS REPORT SUMMARIZES 39 MALFUNCTIONS. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL RF310F VENA CAVA FILTER EXPERIENCED A PATIENT DEVICE INTERACTION PROBLEM AND PATIENT-DEVICE INCOMPATIBILITY. THESE REPORTS WERE RECEIVED FROM VARIOUS SOURCES. THESE MALFUNCTIONS INVOLVED PATIENTS WITH NO PATIENT CONSEQUENCES. 15 PATIENTS RANGED FROM 37-84 YEARS OF AGE. ONE PATIENT WEIGHS 202 LBS. OF THE REPORTED PATIENTS, 14 WERE MALE AND 7 WERE FEMALE. THE REST OF THE PATIENTS' AGE, WEIGHT, AND GENDER WERE NOT PROVIDED.
THIS REPORT SUMMARIZES (B)(4) MALFUNCTIONS. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL RF310F VENA CAVA FILTER EXPERIENCED A PATIENT-DEVICE INTERACTION PROBLEM. THESE REPORTS WERE RECEIVED FROM VARIOUS SOURCES. THESE MALFUNCTIONS INVOLVES PATIENTS WITH NO PATIENT CONSEQUENCES. TWELVE PATIENTS RANGED FROM 39-82 YEARS OF AGE. ONE PATIENT WEIGHED 202 LBS. OF THE REPORTED PATIENTS, (B)(4) WERE MALE AND 5 WERE FEMALE. THE REST OF THE PATIENTS' AGE, WEIGHT, AND GENDER WERE NOT PROVIDED.
THIS REPORT SUMMARIZES 42 MALFUNCTIONS. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL RF310F VENA CAVA FILTER EXPERIENCED A PATIENT DEVICE INTERACTION PROBLEM. THESE REPORTS WERE RECEIVED FROM VARIOUS SOURCES. THESE MALFUNCTIONS INVOLVES PATIENTS WITH NO PATIENT CONSEQUENCES. TWELVE PATIENTS RANGED FROM 20-82 YEARS OF AGE. THREE PATIENT RANGED FROM 174-202 LBS. OF THE REPORTED PATIENTS, 9 WERE MALE AND 7 WERE FEMALE. THE REST OF THE PATIENTS' AGE, WEIGHT, AND GENDER WERE NOT PROVIDED.
THIS REPORT SUMMARIZES 33 MALFUNCTIONS. A REVIEW OF THE REPORTED INFORMATION INDICATES THAT MODEL RF310F VENA CAVA FILTER ALLEGEDLY EXPERIENCED PERFORATION. THESE INFORMATION'S WERE RECEIVED FROM VARIOUS SOURCES. ALL THE THIRTY THREE MALFUNCTIONS WERE INVOLVED PATIENTS WITH NO REPORTED CONSEQUENCES. OF THE 33 PATIENTS, 21 WERE MALE AND 11 WERE FEMALE, 28 PATIENTS AGE RANGED BETWEEN 30-84 YEARS AND 5 PATIENTS WEIGHS IN THE RANGE BETWEEN 202 - 439 LBS. ALL OTHER PATIENT DETAILS WERE NOT PROVIDED.
THIS REPORT SUMMARIZES 42 MALFUNCTIONS. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL RF310F VENA CAVA FILTER EXPERIENCED A PATIENT-DEVICE INTERACTION PROBLEM. THESE REPORTS WERE RECEIVED FROM VARIOUS SOURCES. THESE MALFUNCTIONS INVOLVES PATIENTS WITH NO PATIENT CONSEQUENCES. ALL 42 DEVICES WERE USED IN THE PATIENT. THE PATIENTS RANGED FROM 39-82 YEARS OF AGE. 1 PATIENT WEIGHS 202 LBS. OF THE REPORTED PATIENTS, 8 WERE MALE AND 4 WERE FEMALE. THE REST OF THE PATIENT AGE, WEIGHT, AND GENDER WERE NOT PROVIDED.
THIS REPORT SUMMARIZES 36 MALFUNCTIONS. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL RF310F VENA CAVA FILTER EXPERIENCED A PATIENT DEVICE INTERACTION PROBLEM AND PATIENT-DEVICE INCOMPATIBILITY. THESE REPORTS WERE RECEIVED FROM VARIOUS SOURCES. THESE MALFUNCTIONS INVOLVED PATIENTS WITH NO PATIENT CONSEQUENCES. OF THE 36 PATIENTS, 9 WERE REPORTED TO BE FEMALE AND 19 WERE MALE. THE PATIENTS WERE REPORTED TO BE IN THE AGE RANGE OF 37 TO 84 YEARS OLD AND WEIGHING 202 TO 439 LBS. THE REST OF THE PATIENT'S DETAILS WERE NOT PROVIDED.
THIS REPORT SUMMARIZES 42 MALFUNCTIONS. A REVIEW OF THE EVENTS INDICATED THAT MODEL RF310F VENA CAVA FILTER EXPERIENCED A PATIENT-DEVICE INTERACTION PROBLEM. THESE REPORTS WERE RECEIVED FROM VARIOUS SOURCES. ALL 42 DEVICES WERE USED IN THE PATIENT. PATIENT INFORMATION WAS PROVIDED FOR 12. THE PATIENTS RANGED FROM 39-82 YEARS OF AGE. 1 PATIENT WEIGHS (B)(6). OF THE REPORTED PATIENTS, 8 WERE MALE AND 4 WERE FEMALE. THE REST OF THE PATIENT AGE, WEIGHT, AND GENDER IS UNKNOWN. THERE WAS NO REPORTED PATIENT INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 622617 | G2 FILTER | VENA CAVA FILTER | DTK | BARD PERIPHERAL VASCULAR, INC. | GFRE4509,GFSH3624,GFTJ1623 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |