BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER
Report
- Report Number
- 1710034-2018-00058
- 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
- 30382903814238
- PMA / PMN Number
- K952861
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
INVESTIGATION SUMMARY: PICTURE SAMPLES WERE RECEIVED FOR EVALUATION BY OUR QUALITY ENGINEER TEAM. UPON EXAMINATION, 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. PROPER PERSONNEL HAVE BEEN NOTIFIED OF THIS ISSUE FOR FURTHER REVIEW. 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: 6049955 ¿ THE LOT NUMBER WAS PACKAGED ON PACKAGING LINE 9 FROM FEBRUARY 25, 2016 THRU FEBRUARY 27, 2016, MARCH 10, 2016 THRU MARCH 10, 2016 AND ON PACKAGING LINE 11 FROM APRIL 24, 2016 THRU APRIL 24, 2016 6113638 ¿ THE LOT NUMBER WAS PACKAGED ON PACKAGING LINE 8 FROM APRIL 28, 2016 THRU APRIL 29, 2016 AND ON PACKAGING LINE 11 FROM MAY 1, 2016 THRU MAY 6 2016. 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 (INCLUDING BUT NOT LIMITED TO) 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 (B)(4). VISUAL ANALYSIS OBSERVATIONS: ALTHOUGH OBSERVATIONS AND TESTING COULD NOT BE PERFORMED BECAUSE A SAMPLE WAS NOT RECEIVED FOR INVESTIGATION, THERE WERE 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 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. (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 #: 4017706, MEDICAL DEVICE EXPIRATION DATE: 2017-01-31, DEVICE MANUFACTURE DATE: 2014-01-17. MEDICAL DEVICE LOT #: 4045585, MEDICAL DEVICE EXPIRATION DATE: 2017-02-28, DEVICE MANUFACTURE DATE: 2014-02-14. MEDICAL DEVICE LOT #: 4057615, MEDICAL DEVICE EXPIRATION DATE: 2017-03-31, DEVICE MANUFACTURE DATE: 2014-02-26. MEDICAL DEVICE LOT #: 4071715, MEDICAL DEVICE EXPIRATION DATE: 2017-03-31, DEVICE MANUFACTURE DATE: 2014-03-12. MEDICAL DEVICE LOT #: 4090950, MEDICAL DEVICE EXPIRATION DATE: 2017-03-31, DEVICE MANUFACTURE DATE: 2014-03-31. MEDICAL DEVICE LOT #: 4094833, MEDICAL DEVICE EXPIRATION DATE: 2017-04-30, DEVICE MANUFACTURE DATE: 2014-04-04. MEDICAL DEVICE LOT #: 4114696, MEDICAL DEVICE EXPIRATION DATE: 2017-04-30, DEVICE MANUFACTURE DATE: 2014-04-24. MEDICAL DEVICE LOT #: 4139791, MEDICAL DEVICE EXPIRATION DATE: 2017-05-31, DEVICE MANUFACTURE DATE: 2014-05-19. MEDICAL DEVICE LOT #: 4155501, MEDICAL DEVICE EXPIRATION DATE: 2017-06-30, DEVICE MANUFACTURE DATE: 2014-06-04. MEDICAL DEVICE LOT #: 4273790, MEDICAL DEVICE EXPIRATION DATE: 2017-10-31, DEVICE MANUFACTURE DATE: 2014-09-30. MEDICAL DEVICE LOT #: 4287665, MEDICAL DEVICE EXPIRATION DATE: 2017-10-31, DEVICE MANUFACTURE DATE: 2014-10-14. MEDICAL DEVICE LOT #: 4330725, MEDICAL DEVICE EXPIRATION DATE: 2017-12-31, DEVICE MANUFACTURE DATE: 2014-11-26. MEDICAL DEVICE LOT #: 4338826, MEDICAL DEVICE EXPIRATION DATE: 2017-12-31, DEVICE MANUFACTURE DATE: 2014-12-04. MEDICAL DEVICE LOT #: 5030531, MEDICAL DEVICE EXPIRATION DATE: 2018-02-28, DEVICE MANUFACTURE DATE: 2015-01-30. MEDICAL DEVICE LOT #: 5040553, MEDICAL DEVICE EXPIRATION DATE: 2018-02-28, DEVICE MANUFACTURE DATE: 2015-02-09. MEDICAL DEVICE LOT #: 5044673, MEDICAL DEVICE EXPIRATION DATE: 2018-02-28, DEVICE MANUFACTURE DATE: 2015-02-13. MEDICAL DEVICE LOT #: 5051895, MEDICAL DEVICE EXPIRATION DATE: 2018-02-28, DEVICE MANUFACTURE DATE: 2015-02-20. MEDICAL DEVICE LOT #: 5063840, MEDICAL DEVICE EXPIRATION DATE:2018-03-31, DEVICE MANUFACTURE DATE: 2015-03-04. MEDICAL DEVICE LOT #: 5068872, MEDICAL DEVICE EXPIRATION DATE: 2018-03-31, DEVICE MANUFACTURE DATE: 2015-03-09. MEDICAL DEVICE LOT #: 5198572, MEDICAL DEVICE EXPIRATION DATE: 2018-06-30, DEVICE MANUFACTURE DATE: 2015-07-17. MEDICAL DEVICE LOT #: 5232640, MEDICAL DEVICE EXPIRATION DATE: 2018-07-31, DEVICE MANUFACTURE DATE: 2015-08-20. MEDICAL DEVICE LOT #: 5254633, MEDICAL DEVICE EXPIRATION DATE: 2018-08-31, DEVICE MANUFACTURE DATE: 2015-09-11. MEDICAL DEVICE LOT #: 5323640, MEDICAL DEVICE EXPIRATION DATE: 2018-10-31, DEVICE MANUFACTURE DATE: 2015-11-19. MEDICAL DEVICE LOT #: 5324879, MEDICAL DEVICE EXPIRATION DATE: 2018-10-31, DEVICE MANUFACTURE DATE: 2015-11-20. MEDICAL DEVICE LOT #: 6007719, MEDICAL DEVICE EXPIRATION DATE: 2018-12-31, DEVICE MANUFACTURE DATE:2016-01-07. MEDICAL DEVICE LOT #: 6007764, MEDICAL DEVICE EXPIRATION DATE: 2018-12-31, DEVICE MANUFACTURE DATE: 2016-01-07. MEDICAL DEVICE LOT #: 6041865, MEDICAL DEVICE EXPIRATION DATE: 2019-01-31, DEVICE MANUFACTURE DATE: 2016-02-10. MEDICAL DEVICE LOT #: 6053680, MEDICAL DEVICE EXPIRATION DATE: 2019-01-31, DEVICE MANUFACTURE DATE: 2016-02-23. MEDICAL DEVICE LOT #: 6063953, MEDICAL DEVICE EXPIRATION DATE: 2019-02-28, DEVICE MANUFACTURE DATE: 2016-03-04. MEDICAL DEVICE LOT #: 6102758, MEDICAL DEVICE EXPIRATION DATE: 2019-03-31, DEVICE MANUFACTURE DATE:2016-04-11. MEDICAL DEVICE LOT #: 6119747, MEDICAL DEVICE EXPIRATION DATE: 2019-04-30, DEVICE MANUFACTURE DATE: 2016-04-28. MEDICAL DEVICE LOT #: 7017600, MEDICAL DEVICE EXPIRATION DATE: 2019-12-31, DEVICE MANUFACTURE DATE: 2017-01-30. MEDICAL DEVICE LOT #: 7137823, MEDICAL DEVICE EXPIRATION DATE: 2020-04-30, DEVICE MANUFACTURE DATE: 2017-05-17.
INVESTIGATION SUMMARY: LOT ANALYSIS 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: RECEIVED A TOTAL OF 170 UNUSED IAG 22GA UNITS IN PARTIALLY OPENED PACKAGES. VISUAL/MICROSCOPIC EXAMINATION: THE PACKAGES WERE PARTIALLY OPENED AT BOTH ENDS, TOP OF, OR THE BOTTOM OF THE BLISTER PACKS. 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. VISUAL OF THE ATTACHED PHOTOS: ALTHOUGH OBSERVATIONS AND TESTING COULD NOT BE PERFORMED BECAUSE A SAMPLE WAS NOT RECEIVED FOR INVESTIGATION, THERE WERE PHOTOS SUBMITTED THAT WERE REVIEWED. LOT NO. 6049955 ¿ PART NO. 381423 PHOTO 1 DISPLAYED THE GAUGE DESCRIPTION AND FLOW RATE ON A BLUE BLOCK. PHOTO 2 DISPLAYED THE LOT NUMBER AND THE EXPIRATION DATE. PHOTO 3 DISPLAYED THE END OF THE BLISTER PACK HAD A PARTIAL OPENED SEAL. PHOTO 4 DISPLAYED THE SIDE OF THE BLISTER PACK HAD A PARTIALLY OPENED SEAL. LOT NO. 6113638 ¿ PART NO. 381423 PHOTO 22 DISPLAYED THE GAUGE DESCRIPTION AND FLOW RATE ON A BLUE BLOCK. PHOTO 23 DISPLAYED THE LOT NUMBER AND THE EXPIRATION DATE. PHOTO 24 DISPLAYED AN OPENED SEAL THE TOP OF THE BLISTER PACK. 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 AND TESTING COULD NOT BE PERFORMED BECAUSE UNITS WERE NOT RECEIVED FOR THE FOLLOWING LOT NUMBERS. 4017706, 4114696, 4338826, 5030531, 7017600 AND 7137823 NOTE: THE LOT NUMBER THAT START WITH ¿4¿ ARE PASSED THE EXPIRATION DATE. INVESTIGATION CONCLUSION: INVESTIGATION SAMPLES(S) MEET MANUFACTURING SPECIFICATIONS: YES: THE RETURNED UNITS PROVIDED FOR EVALUATION FOR THIS INCIDENT MET THE MANUFACTURING SPECIFICATION REQUIREMENTS. THE DEFECT PACKAGE DAMAGE/DEFECTIVE/OTHER, AS STATED IN THE SUBJECT OF THE PIR WAS CONFIRMED WITH THE RETURNED UNITS. EVEN THOUGH THE PACKAGES CAME PARTIALLY OPENED, ALL THE PROCESSES CHARACTERISTICS THAT DIRECTLY INFLUENCE THE SEAL STRENGTH ARE: SEAL TRANSFER AND TOP WEB GLUE, MEASURED WITHIN SPECIFICATION. NO ANOMALIES WERE FOUND.
DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 6049955. MEDICAL DEVICE EXPIRATION DATE: 2019-01-31. DEVICE MANUFACTURE DATE: 2016-02-19. MEDICAL DEVICE LOT #: 6113638. MEDICAL DEVICE EXPIRATION DATE: 2019-03-31. DEVICE MANUFACTURE DATE: 2016-04-22. 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 |
|---|---|---|---|---|---|---|---|
| 124581 | BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER | INTRAVASCULAR CATHETER | FOZ | BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. | SEE H.10 | 30382903814238 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |