BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER
Report
- Report Number
- 1710034-2018-00060
- Event Type
- Malfunction
- Date Received
- February 19, 2018
- Date of Event
- February 3, 2018
- Report Date
- March 29, 2018
- Manufacturer
- BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
- Product Code
- FOZ
- UDI-DI
- 30382903814122
- PMA / PMN Number
- K952861
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
H.6. INVESTIGATION SUMMARY: PR #: 265895 CR#: 305566 TYPE: MDR WITH SAMPLES PART #: 381423 LOT #: ADDITIONAL LOT NUMBERS 4339880, 4027561, 4031809, 4042726, 4045573, 4078780, 4107724, 4219572, 5070904, 5079628, 5168921, AND 5188717. AS REPORTED CODE: PACKAGE SEAL INTEGRITY POOR/QUESTIONABLE EVENT DESCRIPTION: PART NO: 381412 BATCH NO: 4339880, IT WAS REPORTED THAT THE PACKAGES WERE PREMATURELY OPENING. LOT ANALYSIS DEVICE/BATCH HISTORY RECORD REVIEW: YES REASON: DHR¿S ARE AVAILABLE FOR REVIEWS AS NEEDED AND ARE REQUIRED FOR QUALITY ISSUES RELATING TO PRODUCT TRACEABILITY OR IF THE REPORTED INCIDENT IS A MEDICAL DEVICE REPORTABLE (MDR). FINDINGS: AS THIS COMPLAINT WAS A MDR; -DHR REVIEW WAS PERFORMED ON THE FOLLOWING LOT NUMBERS: 4339880 ¿ THE LOT NUMBER WAS PACKAGED ON AFA PACKAGING LINE 8 FROM DECEMBER 13, 2016 THRU DECEMBER 15, 2016. MARCH 25, 2017 4027561 ¿ THE LOT NUMBER WAS PACKAGED ON AFA PACKAGING LINE 11 FROM JANUARY 30, 2014 THRU FEBRUARY 4, 2014. 4031809 ¿ THE LOT NUMBER WAS PACKAGED ON AFA PACKAGING LINE 11 FROM FEBRUARY 4, 2014 THRU FEBRUARY 7, 2014. 4042726 ¿ THE LOT NUMBER WAS PACKAGED ON AFA PACKAGING LINE 9 FROM FEBRUARY 16, 2014 THRU FEBRUARY 20, 2014. 4045573 ¿ THE LOT NUMBER WAS PACKAGED ON AFA PACKAGING LINE 9 FROM FEBRUARY 22, 2014 THRU FEBRUARY 23, 2014. 4078780 ¿ THE LOT NUMBER WAS PACKAGED ON AFA PACKAGING LINE 11 FROM MARCH 24, 2014 THRU MARCH 30, 2014. 4107724 ¿ THE LOT NUMBER WAS PACKAGED ON AFA PACKAGING LINE 11 FROM MARCH 30, 2014 THRU APRIL 1, 2014. 4219572 ¿ THE LOT NUMBER WAS PACKAGED ON AFA PACKAGING LINE 8 FROM AUGUST 18, 2014 THRU AUGUST 22, 2014. 5070904 ¿ THE LOT NUMBER WAS PACKAGED ON AFA PACKAGING LINE 8 FROM MARCH 13, 2015 THRU MARCH 14, 2015. 5079628 ¿ THE LOT NUMBER WAS PACKAGED ON AFA PACKAGING LINE 9 FROM MARCH 30, 2015 THRU MARCH 31, 2015. PACKAGING LINE 8 FROM APRIL 14, 2015 THRU APRIL 16, 2015. 5168921 ¿ THE LOT NUMBER WAS PACKAGED ON AFA PACKAGING LINE 8 FROM JUNE 21, 2015 THRU JUNE 26, 2015. PACKAGING LINE 11 FROM JULY 27, 2015 THRU JULY 28, 2015. 5188717 ¿ THE LOT NUMBER WAS PACKAGED ON AFA PACKAGING LINE 9 FROM JULY 13, 2015 THRU JULY 15, 2015. THE REVIEW OF THE DHR¿S IT WAS CONCLUDED THAT ALL REQUIRED CHALLENGES SAMPLES AND TESTING WAS PERFORMED PER SPECIFICATION IN ACCORDANCE WITH THE SET-UP AND IN PROCESS SAMPLING PLANS. PER REVIEW IT WAS NOTED THAT THERE WERE NO REJECT ACTIVITY FINDINGS THROUGHOUT THE BUILD OF THIS LOT THAT WOULD IMPACT UPON THE QUALITY OF THE PRODUCT. SET-UP AND IN PROCESS SAMPLES (INCLUDED BUT NOT LIMITED) BLISTER THICKNESS, BAD SEAL/CUT/HOLES, SEAL TRANSFER WIDTH AND PACKAGE LEAK TEST WERE PERFORMED ON VARIOUS STAGES THROUGHOUT THE PROCESS, ALL THE INSPECTIONS PASSED PER SPECIFICATIONS. QN / SAP DATABASE REVIEW: NO. REASON: A REVIEW OF THE QN/SAP DATABASE IS NOT REQUIRED FOR A S1 ¿ O1 LEVEL A INVESTIGATION PER MS-QS-083 VISUAL ANALYSIS OBSERVATIONS: RECEIVED A TOTAL OF 91 UNUSED IAG 24GA UNITS IN PARTIALLY OPENED PACKAGES ASSOCIATED WITH INVESTIGATION CR #305566 AS LISTED BELOW: 12 UNITS FROM LOT #4339880. 8 UNITS FROM LOT #4027561. 2 UNITS FROM LOT #4031809. 7 UNITS FROM LOT #4042726. 10 UNITS FROM LOT #4045573. 8 UNITS FROM LOT #4078780. 15 UNITS FROM LOT #4107724. 9 UNITS FROM LOT #4219572. 6 UNITS FROM LOT #5070904. 4 UNIT FROM LOT #5079628. 6 UNITS FROM LOT #5168921. 4 UNITS FROM LOT #5188717. VISUAL/MICROSCOPIC EXAMINATION: THE PACKAGES WERE PARTIALLY OPENED AT TOP AND/OR THE BOTTOM OF THE BLISTER PACKS ON THE FOLLOWING LOT NUMBERS: 4339880, 4027561, 4031809, 4042726, 4045573, 4078780, 4107724, 4219572, 5070904, 5079628, 5168921 AND 5188717. THE PRODUCT CHARACTERISTICS REQUIRE A MINIMUM OF 1/8¿ SEAL TRANSFER. PER OBSERVATION OF THE PHOTOS PROVIDED THIS CHARACTERISTIC WAS MET. IN ADDITION, THE BOTTOM WEB IN THE PHOTOS REVEALED EVIDENCE OF ADEQUATE TRANSFER (ADHESIVE) FROM THE PAPER TOP WEB AT THE OPEN SEALS AND PARTIALLY OPEN SEALS OF THE PACKAGES (BLISTER PACKS). THE KEY VARIABLES THAT AFFECT SEAL STRENGTH ARE: SEAL TRANSFER/WIDTH AND PAPER TOP WEB GLUE. BOTH VARIABLES WERE INCLUDED IN THE INVESTIGATION. NOTE: THE LOT NUMBER THAT STAR WITH ¿4¿ ARE PASSED THE EXPIRATION DATE. TEST DESCRIPTION: METHOD NO.: RESULTS: VISUAL PHOTOS N/A SEE OBSERVATIONS AND TESTING INVESTIGATION SAMPLES(S) MEET MANUFACTURING SPECIFICATIONS: YES: THE RETURNED UNITS PROVIDED FOR EVALUATION FOR THIS INCIDENT MET THE MANUFACTURING SPECIFICATION REQUIREMENTS. CONCLUSIONS: THE DEFECT OF PACKAGE SEAL INTEGRITY POOR/QUESTIONABLE AS STATED IN EVENT DESCRIPTION WAS CONFIRMED WITH THE RETURNED UNITS. NO ANOMALIES WERE FOUND AND ALL THE PROCESS CHARACTERISTICS THAT DIRECTLY INFLUENCE THE SEAL STRENGTH WERE OBSERVED TO BE WITHIN SPECIFICATION. THE UNITS WERE ACCEPTABLE PER SPECIFICATION REQUIREMENTS. DID THE EVALUATION CONFIRM THE CUSTOMER'S EXPERIENCE WITH THE BD PRODUCT? YES; THE CUSTOMER EXPERIENCE WAS CONFIRMED BASED ON THE EVALUATION THAT WAS PERFORMED ON THE RETURNED UNIT. WERE WE ABLE TO REPRODUCE THE CUSTOMER'S EXPERIENCE WITH THE BD PRODUCT? NO; IT WAS NOT NECESSARY TO ACHIEVE REPRODUCTION OF THE CUSTOMER¿S EXPERIENCE, AS THE DEFECT WAS CONFIRMED. WAS THE DEVICE USED FOR TREATMENT OR DIAGNOSIS? TREATMENT INVESTIGATION CONCLUSION: RELATIONSHIP OF DEVICE TO THE REPORTED INCIDENT: INDETERMINATE COMMENT: ALTHOUGH THE PACKAGES WERE OBSERVED TO BE PARTIALLY OPENED, THERE WAS NO PHYSICAL EVIDENCE TO CONFIRM OR TO SUPPORT MANUFACTURING PROCESS RELATED ISSUES FOR THE DEFECT.
INVESTIGATION SUMMARY: BD RECEIVED PICTURE SAMPLES FOR EVALUATION. THE PACKAGES WERE OBSERVED PARTIALLY OPEN. A DEVICE HISTORY RECORD REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION OF THE PROVIDED BATCH NUMBER THAT COULD HAVE CONTRIBUTED TO THE OBSERVED DEFECT. ALTHOUGH THE PACKAGES WERE OBSERVED TO BE PARTIALLY OPENED, THERE WAS NO PHYSICAL EVIDENCE TO CONFIRM OR TO SUPPORT MANUFACTURING PROCESS RELATED ISSUES FROM THE PROVIDED PICTURES, THEREFORE, A ROOT CAUSE COULD NOT BE DETERMINED. LOT ANALYSIS DEVICE/BATCH HISTORY RECORD REVIEW: YES REASON: DHR¿S ARE AVAILABLE FOR REVIEWS AS NEEDED AND ARE REQUIRED FOR QUALITY ISSUES RELATING TO PRODUCT TRACEABILITY OR IF THE REPORTED INCIDENT IS A MEDICAL DEVICE REPORTABLE (MDR). FINDINGS: AS THIS COMPLAINT WAS A MDR; -DHR REVIEW WAS PERFORMED ON THE FOLLOWING LOT NUMBERS: 4339880 ¿ THE LOT NUMBER WAS PACKAGED ON PACKAGING LINE 8 FROM DECEMBER 13, 2016 THRU DECEMBER 15, 2016. MARCH 25, 2017 THE REVIEW OF THE DHR¿S IT WAS CONCLUDED THAT ALL REQUIRED CHALLENGES SAMPLES AND TESTING WAS PERFORMED PER SPECIFICATION IN ACCORDANCE WITH THE SET-UP AND IN PROCESS SAMPLING PLANS. PER REVIEW IT WAS NOTED THAT THERE WERE NO REJECT ACTIVITY FINDINGS THROUGHOUT THE BUILD OF THIS LOT THAT WOULD IMPACT UPON THE QUALITY OF THE PRODUCT. SET-UP AND IN PROCESS SAMPLES (INCLUDED BUT NOT LIMITED) BLISTER THICKNESS, BAD SEAL/CUT/HOLES, SEAL TRANSFER WIDTH AND PACKAGE LEAK TEST WERE PERFORMED ON VARIOUS STAGES THROUGHOUT THE PROCESS, ALL THE INSPECTIONS PASSED PER SPECIFICATIONS. VISUAL ANALYSIS OBSERVATIONS: ALTHOUGH OBSERVATIONS AND TESTING COULD NOT BE PERFORMED BECAUSE A SAMPLE WAS NOT RECEIVED FOR INVESTIGATION, THERE WERE TWO PHOTOS SUBMITTED THAT WERE REVIEWED. THE PRODUCT CHARACTERISTICS REQUIRE A MINIMUM OF 1/8¿ SEAL TRANSFER. PER OBSERVATION OF THE PHOTOS PROVIDED THIS CHARACTERISTIC WAS MET. IN ADDITION, THE BOTTOM WEB IN THE PHOTOS REVEALED EVIDENCE OF ADEQUATE TRANSFER (ADHESIVE) FROM THE PAPER TOP WEB AT THE OPEN SEALS AND PARTIALLY OPEN SEALS OF THE PACKAGES (BLISTER PACKS). THE KEY VARIABLES THAT AFFECT SEAL STRENGTH ARE: SEAL TRANSFER/WIDTH AND PAPER TOP WEB GLUE. BOTH VARIABLES WERE INCLUDED IN THE OBSERVATIONS INVESTIGATION SAMPLES(S) MEET MANUFACTURING SPECIFICATIONS: YES: ALTHOUGH THE PACKAGES WERE PARTIALLY OPEN AT THE TOP, THE PHOTOS EVALUATED FOR THIS INCIDENT REVEALED THE UNITS TO BE ACCEPTABLE PER THE MANUFACTURING SPECIFICATION REQUIREMENTS. CONCLUSIONS: THE DEFECT PACKAGE SEAL INTEGRITY POOR/QUESTIONABLE, AS STATED AS THE REPORTED CODE WAS CONFIRMED BASED ON THE EVALUATION OF THE PROVIDED PHOTOS. EVEN THOUGH THE PACKAGES CAME PARTIALLY OPENED, ALL THE PROCESSES CHARACTERISTICS THAT DIRECTLY INFLUENCE THE SEAL STRENGTH WERE OBSERVED TO BE WITHIN SPECIFICATION. INVESTIGATION CONCLUSION: RELATIONSHIP OF DEVICE TO THE REPORTED INCIDENT: INDETERMINATE (B)(4) HAS BEEN OPENED TO INVESTIGATE THE PACKAGE OPEN SEAL DEFECTS AND IMPLEMENT CORRECTIVE ACTIONS.
ADDITIONAL INFORMATION WAS RECEIVED FOR THE MEDICAL DEVICE LOT NUMBER(S), DEVICE MANUFACTURING DATE(S), AND DEVICE EXPIRATION DATE(S). THE FOLLOWING FIELD(S) HAVE BEEN UPDATED: MEDICAL DEVICE LOT #: 4027561, MEDICAL DEVICE EXPIRATION DATE: 2017-01-31, DEVICE MANUFACTURE DATE: 2014-01-27. MEDICAL DEVICE LOT #: 4031809, MEDICAL DEVICE EXPIRATION DATE: 2017-02-28, DEVICE MANUFACTURE DATE: 2014-01-31. MEDICAL DEVICE LOT #: 4042726, MEDICAL DEVICE EXPIRATION DATE: 2017-02-28, DEVICE MANUFACTURE DATE: 2014-02-11, MEDICAL DEVICE LOT #: 4045573, MEDICAL DEVICE EXPIRATION DATE: 2017-02-28, DEVICE MANUFACTURE DATE: 2014-02-14. MEDICAL DEVICE LOT #: 4078780, MEDICAL DEVICE EXPIRATION DATE: 2017-03-31, DEVICE MANUFACTURE DATE: 2014-03-19. MEDICAL DEVICE LOT #: 4107724, MEDICAL DEVICE EXPIRATION DATE: 2017-04-30, DEVICE MANUFACTURE DATE: 2014-04-17. MEDICAL DEVICE LOT #: 4219572, MEDICAL DEVICE EXPIRATION DATE: 2017-08-31, DEVICE MANUFACTURE DATE: 2014-08-07. MEDICAL DEVICE LOT #: 5070904 MEDICAL DEVICE EXPIRATION DATE: 2018-03-31 DEVICE MANUFACTURE DATE: 2015-03-11 MEDICAL DEVICE LOT #: 5079628, MEDICAL DEVICE EXPIRATION DATE: 2018-03-31, DEVICE MANUFACTURE DATE: 2015-03-20. MEDICAL DEVICE LOT #: 5168921, MEDICAL DEVICE EXPIRATION DATE: 2018-05-31, DEVICE MANUFACTURE DATE: 2015-06-17. MEDICAL DEVICE LOT #:5188717, MEDICAL DEVICE EXPIRATION DATE: 2018-06-30 , DEVICE MANUFACTURE DATE: 2015-07-07.
DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.
IT WAS REPORTED BEFORE USE OF THE BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER THE PACKAGES WERE PREMATURELY OPENED. THE PREMATURE PACKAGING FAILURE IS LEADING TO EXCESSIVE WASTE COSTS BECAUSE THE CATHETERS ARE PULLED BEFORE THEY EXPIRE. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 124614 | BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER | INTRAVASCULAR CATHETER | FOZ | BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. | SEE H.10 | 30382903814122 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |