BD NEXIVA¿ CLOSED IV CATHETER SYSTEM
Report
- Report Number
- 1710034-2022-00759
- Event Type
- Malfunction
- Date Received
- December 7, 2022
- Date of Event
- November 14, 2022
- Report Date
- March 10, 2023
- Manufacturer
- BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
- Product Code
- FOZ
- UDI-DI
- 50382903835176
- PMA / PMN Number
- K183399
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MX
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.
H6: INVESTIGATION SUMMARY: A PHYSICAL SAMPLE WAS NOT AVAILABLE FOR INVESTIGATION BUT BD WAS PROVIDED WITH A PHOTO OF THE ISSUE FOR EVALUATION. OUR QUALITY ENGINEER REVIEWED THE PROVIDED PHOTO AND OBSERVED THE PACKAGING LABELING ONLY. THE ACTUAL DEVICE WAS NOT VISIBLE FOR REVIEW. THEREFORE, BASED OFF THE PROVIDED PHOTO THE ENGINEER WAS UNABLE TO VERIFY THE REPORTED DEFECT. SINCE NO DEFECTS COULD BE IDENTIFIED IN THE PROVIDED PHOTO THE ENGINEER COULD NOT DETERMINE A DEFINITIVE ROOT CAUSE. THE DHR FOR LOT 2122704 HAS BEEN REVIEWED.
THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL? YES. D10: RETURNED TO MANUFACTURER ON: 21-FEB-2023. H6. INVESTIGATION SUMMARY: BD RECEIVED A 20 GAUGE NEXIVA DEVICE FROM LOT 2122704 FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED FOR THE REPORTED LOT AND NO QUALITY ISSUES WERE FOUND DURING PRODUCTION. OUR QUALITY ENGINEER VISUALLY INSPECTED THE RETURNED UNITS AND OBSERVED THAT THE UNIT HAD BEEN USED. THE NEEDLE HAD ALSO DECOUPLED FROM THE CATHETER. NEXT, THE ENGINEER ATTEMPTED TO RECREATE THE REPORTED ISSUE BY RESETTING THE CANNULA WHEN A SCRAPPING NOISE WAS HEARD. FURTHER INVESTIGATION DETERMINED THAT THE SCRAPPING NOISE WAS THE WASHER RUBBING AGAINST THE NEEDLE CREATING FRICTION. THE ENGINEER ATTEMPTED TO RETRACT THE NEEDLE BUT EXPERIENCED RESISTANCE DURING THE ENTIRETY OF THE RETRACTION PROCESS. AFTER RETRACTION, THE ENGINEER DISSECTED THE DEVICE TO INVESTIGATE THE WASHER FURTHER. THE WASHER WAS MEASURED AND FOUND TO BE OUTSIDE OF PRODUCT SPECIFICATIONS. FINALLY, AN INSPECTION OF THE INCOMING RAW MATERIALS PROCESS WAS PERFORMED AND A RAW MATERIAL ENGINEER WAS CONTACTED TO ENSURE THE CERTIFICATE OF COMPLIANCE WAS RECEIVED FOR THE BATCH OF WASHERS ISSUED FOR THE FINISHED GOOD LOT. WHILE LOOKING AT THE COMPLIANCE FOR THE RAW MATERIAL REPORT, IT WAS DISCOVERED THAT ALL THE PAPERWORK WAS COMPLETED CORRECTLY BY THE VENDOR. THEREFORE, BASED OFF THE VISUAL INSPECTION AND TESTING THE ENGINEER WAS ABLE TO VERIFY THE REPORTED DEFECT. IT WAS DETERMINED THAT THIS ISSUE WAS CAUSED BY THE WASHER BEING OUT OF SPECIFICATIONS.
IT WAS REPORTED THAT THE BD NEXIVA¿ CLOSED IV CATHETER SYSTEM EXPERIENCED DIFFICULT SAFETY MECHANISM DISENGAGEMENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: NEXIVA IS VERY ATTACHED, WHEN REMOVING THE BEZEL A SQUEAK IS HEARD AND HAS CAUSED INSECURITY OF USE IN THE AREAS.
IT WAS REPORTED THAT THE BD NEXIVA¿ CLOSED IV CATHETER SYSTEM EXPERIENCED DIFFICULT SAFETY MECHANISM DISENGAGEMENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: NEXIVA IS VERY ATTACHED, WHEN REMOVING THE BEZEL A SQUEAK IS HEARD AND HAS CAUSED INSECURITY OF USE IN THE AREAS.
IT WAS REPORTED THAT THE BD NEXIVA¿ CLOSED IV CATHETER SYSTEM EXPERIENCED DIFFICULT SAFETY MECHANISM DISENGAGEMENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: NEXIVA IS VERY ATTACHED, WHEN REMOVING THE BEZEL A SQUEAK IS HEARD AND HAS CAUSED INSECURITY OF USE IN THE AREAS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2508085 | BD NEXIVA¿ CLOSED IV CATHETER SYSTEM | INTRAVENOUS CATHETER | FOZ | BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. | 383517 | 2122704 | 50382903835176 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |