FDA Adverse Event
Malfunction
Summary report: N
SPROTTE SURETY
MDR report key: 2891761
·
Received November 21, 2012
Report
- Report Number
- 9611612-2012-00012
- Event Type
- Malfunction
- Date Received
- November 21, 2012
- Date of Event
- October 26, 2012
- Report Date
- November 21, 2012
- Manufacturer
- PAJUNK GMBH MEDIZINTECHNOLOGIE
- Product Code
- BSP
- PMA / PMN Number
- 911202
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Description of Event or Problem · 1
(B)(4). EVENT TOOK PLACE IN (B)(6) AND HAS BEEN REPORTED TO THE (B)(4). FROM USERS/INITIAL REPORTERS NARRATIVE: "UPON INJECTING INTO THE PATIENT FLUID WAS SEEN LEAKING FROM THE HUB PART. SPINAL WAS COMPLETED USING ANOTHER SPROTTE SURETY NEEDLE. NEEDLE HAS BEEN GIVEN TO [SALES REPRESENTATIVE] ALONG WITH ANOTHER FROM THE SAME BATCH."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SPROTTE SURETY | 868.5150 ANESTHESIA CONDUCTION NEEDLE. | BSP | PAJUNK GMBH MEDIZINTECHNOLOGIE | 021152-29A | 977 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |