FDA Adverse Event
Malfunction
Summary report: N
BD NEEDLE SFTYGLD 25X5/8 RB MCK
MDR report key: 18393328
·
Received December 26, 2023
Report
- Report Number
- 1213809-2023-01488
- Event Type
- Malfunction
- Date Received
- December 26, 2023
- Date of Event
- November 10, 2023
- Report Date
- December 6, 2023
- Manufacturer
- BECTON DICKINSON MEDICAL SYSTEMS
- Product Code
- FMI
- PMA / PMN Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.
Description of Event or Problem · 0
IT WAS REPORTED THAT THE BD NEEDLE SFTYGLD 25X5/8 RB MCK NEEDLE WAS CLOGGED/BLOCKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WHILE TRYING TO DRAW UP BLOOD, THERE WAS NO OPENING TO DO SO-UNABLE TO DRAW BLOOD." NOTED BEFORE USE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2274381 | BD NEEDLE SFTYGLD 25X5/8 RB MCK | SAFETYGLIDE NEEDLES | FMI | BECTON DICKINSON MEDICAL SYSTEMS | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |