BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER
Report
- Report Number
- 1710034-2023-00294
- Event Type
- Malfunction
- Date Received
- March 21, 2023
- Date of Event
- February 17, 2023
- Report Date
- September 19, 2023
- Manufacturer
- BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
- Product Code
- FOZ
- UDI-DI
- 00382903818235
- PMA / PMN Number
- K952861
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
H6: INVESTIGATION SUMMARY SINCE NO SAMPLES DISPLAYING THE CONDITION REPORTED WERE AVAILABLE FOR EXAMINATION, WE WERE UNABLE TO FULLY INVESTIGATE THIS INCIDENT. A DEVICE HISTORY RECORD REVIEW SHOWED NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING THE PRODUCTION OF THIS BATCH.
THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES, D10: RETURNED TO MANUFACTURER ON: 24-AUG-2023. H6: INVESTIGATION SUMMARY OUR QUALITY ENGINEER INSPECTED THE SAMPLE SUBMITTED FOR EVALUATION. BD RECEIVED ONE USED 22G X 1.00IN. INSYTE AUTOGUARD UNIT FROM LOT NUMBER 2312415. A GROSS VISUAL INSPECTION OF THE RETURNED UNIT FOUND THAT THE NEEDLE WAS PARTIALLY RETRACTED, AND THE NEEDLE WAS BENT AT THE NOTCH. IT IS LIKELY THAT THE BEND WAS CAUSED POST-USE, DURING TRANSIT OF THE PRODUCT, AS YOUR REPORT DOES NOT REPORT A BENT NEEDLE. THE UNIT WAS FURTHER INSPECTED MICROSCOPICALLY TO DETERMINE WHAT WAS PREVENTING THE NEEDLE FROM RETRACTING. MICROSCOPIC INSPECTION FOUND THAT THE END OF THE GRIP, WHICH COUPLES WITH THE BARREL, WAS DEFORMED. THE DEFORMATION WAS BENDING IN, PREVENTING THE NEEDLE HUB FROM RELEASING FULLY INTO THE BARREL. THE REPORTED ISSUE WAS CONFIRMED AND DETERMINED TO BE MANUFACTURING RELATED. DURING MANUFACTURING, THIS TYPE OF DAMAGE MAY OCCUR DUE TO A MACHINE MISALIGNMENT. OPERATORS PERFORM TESTING FOR NEEDLE RETRACTION PER THE QUALITY CONTROL PLAN TO MITIGATE THE OCCURRENCE OF THIS DEFECT. A DEVICE HISTORY RECORD REVIEW SHOWED NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING THE PRODUCTION OF THIS BATCH.
A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.
IT WAS REPORTED THAT THE BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER NEEDLE WOULD NOT RETRACT AFTER PLACING THE KTC. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH: "FOR THE FOLLOWING REASON: IT WAS NOT POSSIBLE TO RETRACT THE NEEDLE AFTER THE PLACEMENT OF THE KTC: THE NURSE ALMOST PRICKED HERSELF. PATIENT CONCERNED? NO".
IT WAS REPORTED THAT THE BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER NEEDLE WOULD NOT RETRACT AFTER PLACING THE KTC. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH: "FOR THE FOLLOWING REASON: IT WAS NOT POSSIBLE TO RETRACT THE NEEDLE AFTER THE PLACEMENT OF THE KTC: THE NURSE ALMOST PRICKED HERSELF. PATIENT CONCERNED? NO."
IT WAS REPORTED THAT THE BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER NEEDLE WOULD NOT RETRACT AFTER PLACING THE KTC. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH: "FOR THE FOLLOWING REASON: IT WAS NOT POSSIBLE TO RETRACT THE NEEDLE AFTER THE PLACEMENT OF THE KTC: THE NURSE ALMOST PRICKED HERSELF. PATIENT CONCERNED? NO".
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 11884 | BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER | INTRAVASCULAR CATHETER | FOZ | BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. | 381823 | 2312415 | 00382903818235 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |