2FR SL W/O GW BULK NON
Report
- Report Number
- 3006260740-2022-03015
- Event Type
- Malfunction
- Date Received
- August 2, 2022
- Date of Event
- July 18, 2022
- Report Date
- November 9, 2022
- Manufacturer
- C.R. BARD, INC. (BASD) -3006260740
- Product Code
- LJS
- PMA / PMN Number
- UNK
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- BR
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
THE MANUFACTURER HAS RECEIVED THE SAMPLE AND IS PENDING EVALUATION. RESULTS ARE EXPECTED SOON. A LOT HISTORY REVIEW (LHR) REVIEW IS NOT POSSIBLE; THE MANUFACTURING LOT NUMBER THAT WAS PROVIDED IS INCORRECT/INVALID.
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. THE FOLLOWING WERE REVIEWED AS PART OF THIS INVESTIGATION: PATIENT SEVERITY, APPLICABLE PREVIOUS INVESTIGATION(S), SAMPLE ANALYSIS, APPLICABLE FMEA DOCUMENTS, APPLICABLE MANUFACTURING RECORDS, AND LABELING. BASED ON A REVIEW OF THIS INFORMATION, THE FOLLOWING WAS CONCLUDED: THE COMPLAINT OF A CATHETER LEAK IS CONFIRMED BUT THE EXACT CAUSE REMAINS UNKNOWN. ONE VIDEO SAMPLE OF A 2 FR PERQCATH CATHETER WAS PROVIDED FOR EVALUATION. THE CATHETER IS BEING HELD OVER A SINK AND IS BEING INFUSED WITH A CLEAR FLUID. THE FLUID IS OBSERVED TO LEAK AT THE PROXIMAL END OF THE CATHETER EXTENDING FROM THE MOLDED WINGED HUB. THE LEAK IS SPRAYING OUTWARDS. THE CHARACTERISTICS OF THE LEAK LOCATION IN THE CATHETER COULD NOT BE CLOSELY INSPECTED FROM THE VIDEO PROVIDED. SINCE A LEAK WAS OBSERVED IN THE VIDEO SAMPLE PROVIDED, THE COMPLAINT IS CONFIRMED BUT THE EXACT CAUSE REMAINS UNKNOWN. A LOT HISTORY REVIEW (LHR) OF REDS2498 SHOWED ONE OTHER SIMILAR PRODUCT COMPLAINT(S) FROM THIS LOT NUMBER.
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. THE FOLLOWING WERE REVIEWED AS PART OF THIS INVESTIGATION: PATIENT SEVERITY, COMPLAINT AND LOT HISTORY REVIEW, APPLICABLE PREVIOUS INVESTIGATION(S), SAMPLE (IF AVAILABLE), APPLICABLE MANUFACTURE RECORDS, AND APPLICABLE FMEA DOCUMENTS. BASED ON A REVIEW OF THIS INFORMATION, THE FOLLOWING WAS CONCLUDED: THE COMPLAINT OF A DAMAGED CATHETER WAS CONFIRMED. THE PRODUCT RETURNED FOR EVALUATION WAS ONE 2 FR PER-Q-CATH. THE DAMAGE OBSERVED IN THE RETURNED SAMPLE WAS CHARACTERISTIC OF OVER-PRESSURIZATION (BURST) DAMAGE. THIS CAN OCCUR THROUGH THE USE OF SYRINGES SMALLER THAN 10ML, BY FLUSHING AGAINST AN OCCLUSION, OR DUE TO EXCESSIVE FORCE APPLIED DURING INFUSION PROCEDURES. THE RETURNED PRODUCT SAMPLE WAS EVALUATED, AND A SPLIT WAS OBSERVED IN THE CATHETER TUBING AT THE DISTAL END OF THE STRAIN RELIEF. THIS CATHETER DAMAGE WAS TYPICAL OF A BURST, AND THE CHARACTERISTICS OBSERVED WHICH SUPPORTED THIS TYPE OF FAILURE INCLUDED: 'C' SHAPED SPLIT. TENSILE WEAKNESS AT THE FRACTURE SITE (DUE TO MATERIAL BALLOONING PRIOR TO BURST) GRANULAR FRACTURE SURFACE TEXTURE (TYPICAL OF TEARING FAILURE MODES). AN EXAMINATION OF THE CATHETER STRUCTURE REVEALED NO POTENTIAL DAMAGE/DEFECT RELATED TO MANUFACTURE OF THE PRODUCT. H3 OTHER TEXT : EVALUATION FINDINGS ARE IN SECTION H11.
IT WAS REPORTED PICC WAS INSERTED ON (B)(6) 2022 FOR ATB WITH OXACILLIN FOR 21 DAYS (D11). TODAY, (B)(6) 2022, A NURSE SENT ME A VIDEO DEMONSTRATING THAT THE SILICONE PRESENTS PARTIAL FRACTURE NEAR THE FIXATION WING, AN INCIDENT OBSERVED DURING THE FLUSHING PERFORMED BY THE SAME PROFESSIONAL.
IT WAS REPORTED PICC WAS INSERTED ON (B)(6) 2022 FOR ATB WITH OXACILLIN FOR 21 DAYS (D11). TODAY, 7/18/2022, A NURSE SENT ME A VIDEO DEMONSTRATING THAT THE SILICONE PRESENTS PARTIAL FRACTURE NEAR THE FIXATION WING, AN INCIDENT OBSERVED DURING THE FLUSHING PERFORMED BY THE SAME PROFESSIONAL. ADDITIONAL INFORMATION: WAS THERE ANY HARM TO THE PATIENT/HEALTH WORKER? THE LOSS OF A CENTRAL CATHETER BEFORE THE END OF THE PROPOSED THERAPY IS ALWAYS A HARM TO THE PATIENT. THE MEDICATIONS THAT THE PATIENT WAS RECEIVING ORDERED ADMINISTRATION VIA A CENTRAL CATHETER, BUT THE PATIENT CONTINUED ON PERIPHERAL VENOUS CATHETER THERAPY. WAS THERE A NEED FOR MEDICAL AND/OR SURGICAL INTERVENTION DUE TO THE EVENT (IMAGING EXAMS, SURGERY, MEDICATION ADMINISTRATION, ETC)? NO HAS THERE BEEN BLOOD OR CHEMOTHERAPY EXPOSURE TO MUCOUS MEMBRANES OR SKIN? NO HOW WAS THE PROCEDURE COMPLETED? PARTIALLY FRACTURED PICC WAS REMOVED FROM THE PATIENT.
IT WAS REPORTED PICC WAS INSERTED ON 07/12/22 FOR ATB WITH OXACILLIN FOR 21 DAYS (D11). TODAY, 7/18/22, A NURSE SENT ME A VIDEO DEMONSTRATING THAT THE SILICONE PRESENTS PARTIAL FRACTURE NEAR THE FIXATION WING, AN INCIDENT OBSERVED DURING THE FLUSHING PERFORMED BY THE SAME PROFESSIONAL. ADDITIONAL INFORMATION: WAS THERE ANY HARM TO THE PATIENT/HEALTH WORKER? THE LOSS OF A CENTRAL CATHETER BEFORE THE END OF THE PROPOSED THERAPY IS ALWAYS A HARM TO THE PATIENT. THE MEDICATIONS THAT THE PATIENT WAS RECEIVING ORDERED ADMINISTRATION VIA A CENTRAL CATHETER, BUT THE PATIENT CONTINUED ON PERIPHERAL VENOUS CATHETER THERAPY. WAS THERE A NEED FOR MEDICAL AND/OR SURGICAL INTERVENTION DUE TO THE EVENT (IMAGING EXAMS, SURGERY, MEDICATION ADMINISTRATION, ETC)? NO. HAS THERE BEEN BLOOD OR CHEMOTHERAPY EXPOSURE TO MUCOUS MEMBRANES OR SKIN? NO. HOW WAS THE PROCEDURE COMPLETED? PARTIALLY FRACTURED PICC WAS REMOVED FROM THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2430743 | 2FR SL W/O GW BULK NON | CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS | LJS | C.R. BARD, INC. (BASD) -3006260740 | N/A | REDS2498 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Other |