BD NEXIVA¿ CLOSED IV CATHETER SYSTEM
Report
- Report Number
- 1710034-2023-01110
- Event Type
- Malfunction
- Date Received
- September 26, 2023
- Date of Event
- August 31, 2023
- Report Date
- November 17, 2023
- Manufacturer
- BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
- Product Code
- FOZ
- UDI-DI
- 30382903835165
- PMA / PMN Number
- K102520
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
H6: INVESTIGATION SUMMARY A PHYSICAL SAMPLE WAS NOT AVAILABLE FOR INVESTIGATION BUT BD WAS PROVIDED WITH A VIDEO OF THE ISSUE FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED FOR THE REPORTED LOT, 2173214, AND NO QUALITY ISSUES WERE FOUND DURING PRODUCTION. OUR QUALITY ENGINEER REVIEWED THE PROVIDED VIDEO AND OBSERVED DROPS OF LIQUID LEAKING FROM THE TIP SHIELD SAFETY MECHANISM AND THE END OF THE NEEDLE COVER. THEREFORE, BASED OFF THE PROVIDED VIDEO THE ENGINEER WAS ABLE TO VERIFY THE REPORTED DEFECT. IT WAS DETERMINED THAT THIS WAS A MANUFACTURING DEFECT BUT WITHOUT KNOWING THE EXTENT OF THE DAMAGE THE ENGINEER COULD NOT DETERMINE A DEFINITIVE ROOT CAUSE.
PR (B)(4) FOLLOW UP MDR FOR UPDATED DEVICE EVALUATION (PHYSICAL SAMPLE RETURNED): ONE PHYSICAL SAMPLE ALONG WITH A VIDEO OF THE INCIDENT WAS PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. THROUGH VISUAL INSPECTION OF THE VIDEO, DROPS OF LIQUID LEAKING FROM THE TIP SHIELD SAFETY MECHANISM AND THE END OF THE NEEDLE COVER WAS OBSERVED. FURTHER EVALUATION OF THE PHYSICAL SAMPLE IDENTIFIED DAMAGE TO THE SEPTUM AND CANISTER, WHICH CREATED THE LEAK OBSERVED. A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED FOR THE REPORTED LOT, 2173214, AND NO QUALITY ISSUES WERE FOUND DURING PRODUCTION. WHILE WE COULD NOT IDENTIFY A DIRECT ISSUE, IT WAS DETERMINED THIS INCIDENT OCCURRED DURING ASSEMBLY LIKELY DUE TO MACHINE MISALIGNMENT WHICH CAN CREATE THE DAMAGE OBSERVED ON THE PROVIDED SAMPLE. MANUFACTURING PERSONNEL HAVE BEEN NOTIFIED OF THIS INCIDENT TO RAISE AWARENESS OF THIS ISSUE AND PREVENT RECURRENCE. H3 OTHER TEXT : SEE MANUFACTURER NARRATIVE.
H.3. 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 FLUID LEAKED FROM THE BD NEXIVA¿ CLOSED IV CATHETER SYSTEM CONNECTION TO THE NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE: "WHEN THE NURSE WAS PREFILLING THE INDWELLING NEEDLE, SHE DISCOVERED FLUID LEAKAGE FROM THE CONNECTION OF THE NEEDLE HANDLE."
IT WAS REPORTED THAT FLUID LEAKED FROM THE BD NEXIVA¿ CLOSED IV CATHETER SYSTEM CONNECTION TO THE NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE: "WHEN THE NURSE WAS PREFILLING THE INDWELLING NEEDLE, SHE DISCOVERED FLUID LEAKAGE FROM THE CONNECTION OF THE NEEDLE HANDLE."
IT WAS REPORTED THAT FLUID LEAKED FROM THE BD NEXIVA¿ CLOSED IV CATHETER SYSTEM CONNECTION TO THE NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE: "WHEN THE NURSE WAS PREFILLING THE INDWELLING NEEDLE, SHE DISCOVERED FLUID LEAKAGE FROM THE CONNECTION OF THE NEEDLE HANDLE".
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1018938 | BD NEXIVA¿ CLOSED IV CATHETER SYSTEM | INTRAVASCULAR CATHETER | FOZ | BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. | 2173214 | 30382903835165 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |