BD ULTRASAFE PASSIVE NEEDLE GUARD
Report
- Report Number
- 3009081593-2024-00012
- Event Type
- Malfunction
- Date Received
- March 29, 2024
- Date of Event
- March 5, 2024
- Report Date
- October 11, 2024
- Manufacturer
- BECTON DICKINSON HUNGARY KFT (BD)
- Product Code
- FMI
- PMA / PMN Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AU
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
H.3. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.
THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D9: DEVICE AVAILABLE FOR EVAL YES, D9: RETURNED TO MANUFACTURER ON: 19-MAR-2024 H.6.: INVESTIGATION SUMMARY: CONFIRMED: REPORTED CONDITION IS WITHIN SPECIFICATION.
IT WAS REPORTED THAT THE 2 OF THE BD ULTRASAFE PASSIVE NEEDLE GUARD COULD NOT ACTIVATE SAFETY GUARD. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DURING ROUTINE FDF CHECK, TWO INJECTOR DEVICES (NSD) HAD THEIR FIXING HOOKS DEFORMED. THIS DEFECT WAS DETECTED WITHIN ONE DEVICE FROM EACH FDF SAMPLE PACKAGE (ONE OUT OF 5 INJECTORS IN START AND ONE OUT OF 5 INJECTORS IN END)
IT WAS REPORTED THAT THE 2 OF THE BD ULTRASAFE PASSIVE NEEDLE GUARD COULD NOT ACTIVATE SAFETY GUARD. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DURING ROUTINE FDF CHECK, TWO INJECTOR DEVICES (NSD) HAD THEIR FIXING HOOKS DEFORMED. THIS DEFECT WAS DETECTED WITHIN ONE DEVICE FROM EACH FDF SAMPLE PACKAGE (ONE OUT OF 5 INJECTORS IN START AND ONE OUT OF 5 INJECTORS IN END).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2258921 | BD ULTRASAFE PASSIVE NEEDLE GUARD | HYPODERMIC SINGLE LUMEN NEEDLE | FMI | BECTON DICKINSON HUNGARY KFT (BD) | 3244971 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |