FDA Adverse Event
Injury
Summary report: N
PENCAN SPINAL NEEDLE TRAY
MDR report key: 13087523
·
Received December 23, 2021
Report
- Report Number
- MW5106280
- Event Type
- Injury
- Date Received
- December 23, 2021
- Date of Event
- December 16, 2021
- Report Date
- December 22, 2021
- Manufacturer
- B. BRAUN MEDICAL INDUSTRIES SDN. BHD.
- Product Code
- BSP
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- WA, US
- Reporter Occupation
- RISK MANAGER
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
SPINAL NEEDLE BROKE WHILE BEING USED FOR SPINAL ANALGESIA. FDA SAFETY REPORT ID # (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1969351 | PENCAN SPINAL NEEDLE TRAY | NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER) | BSP | B. BRAUN MEDICAL INDUSTRIES SDN. BHD. | 0061782587 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 76 YR | Male | Required Intervention |