FDA Adverse Event
Malfunction
Summary report: N
BD ULTRASAFE PLUS¿ X100L PNG CLEAR
MDR report key: 20631970
·
Received November 7, 2024
Report
- Report Number
- 3009081593-2024-00033
- Event Type
- Malfunction
- Date Received
- November 7, 2024
- Date of Event
- October 22, 2024
- Report Date
- November 5, 2024
- Manufacturer
- BECTON DICKINSON HUNGARY KFT (BD)
- Product Code
- FMI
- PMA / PMN Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH ADDITIONAL LOT NUMBER IS AS FOLLOWS: D4. MEDICAL DEVICE LOT#: 3140551, D4. MEDICAL DEVICE EXPIRATION DATE: 30APR2027, H4. DEVICE MANUFACTURE DATE: 20MAY2023, D4. MEDICAL DEVICE LOT#: 3132727, D4. MEDICAL DEVICE EXPIRATION DATE: 30APR2027, H4. DEVICE MANUFACTURE DATE: 12MAY2023. E.1. THE CUSTOMER'S ADDRESS IS UNKNOWN. UNKNOWN, (B)(6) USA HAS BEEN USED AS A DEFAULT. H.6. INVESTIGATION SUMMARY: UNCONFIRMED: NO SAMPLE/EVIDENCE PROVIDED.
Description of Event or Problem · 0
IT WAS REPORTED THAT THE BD ULTRASAFE PLUS¿ X100L PNG CLEAR PRE ACTIVATED PRIOR TO USE. THE FOLLOWING WAS RECEIVED FROM THE INITIAL REPORTER: NSD ACTIVATES EARLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1626424 | BD ULTRASAFE PLUS¿ X100L PNG CLEAR | HYPODERMIC SINGLE LUMEN NEEDLE | FMI | BECTON DICKINSON HUNGARY KFT (BD) | SEE H.10 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |