FDA Adverse Event
Malfunction
Summary report: N
BD ULTRASAFE¿
MDR report key: 22884238
·
Received August 25, 2025
Report
- Report Number
- 3009081593-2025-00039
- Event Type
- Malfunction
- Date Received
- August 25, 2025
- Date of Event
- August 13, 2025
- Report Date
- September 10, 2025
- Manufacturer
- BECTON DICKINSON HUNGARY KFT (BD)
- Product Code
- FMI
- PMA / PMN Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SZ
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
H.3. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.
Additional Manufacturer Narrative · 0
H.6. INVESTIGATION SUMMARY: CONFIRMED: REPORTED CONDITION WAS OBSERVED AT BDM-PS.
Description of Event or Problem · 0
IT WAS REPORTED THE BD ULTRASAFE X100LG2XL PNG BLUE TINT ACTIVATED EARLY. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: NSD ACTIVATES EARLY.
Description of Event or Problem · 0
IT WAS REPORTED THE BD ULTRASAFE X100LG2XL PNG BLUE TINT ACTIVATED EARLY. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: (B)(6).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2391031 | BD ULTRASAFE¿ | PISTON SYRINGE | FMI | BECTON DICKINSON HUNGARY KFT (BD) | 3315084 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |