FDA Adverse Event
Injury
Summary report: N
SPROTTE STANDARD
MDR report key: 8415333
·
Received March 13, 2019
Report
- Report Number
- 9611612-2019-00004
- Event Type
- Injury
- Date Received
- March 13, 2019
- Date of Event
- February 13, 2019
- Report Date
- March 13, 2019
- Manufacturer
- PAJUNK GMBH MEDIZINTECHNOLOGIE
- Product Code
- BSP
- UDI-DI
- 14048223000257
- PMA / PMN Number
- K911202
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- RISK MANAGER
Narratives
Additional Manufacturer Narrative · 1
EVENT TOOK PLACE IN (B)(6) AND HAS BEEN REPORTED THROUGH (B)(6) DISTRIBUTION SUBSIDIARY PAJUNK MEDICAL PRODUKTE GMBH. CURRENTLY THE DATA IS POOR AND THE DEVICE HAS NOT BEEN RETURNED/ ANALYSED. AS SOON AS FURTHER DATA WILL BE AVAILABLE A FOLLOW UP REPORT WILL BE SENT IN TO THE AGENCY.
Description of Event or Problem · 1
(B)(4). TENTATIVE SUMMARIZING TRANSLATION OF INITIAL REPORTER´S NARRATIVE: BREAKAGE OF NEEDLE. PIECE REMAINED IN PATIENT AND WAS REMOVED IN ANOTHER SURGERY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 210071 | SPROTTE STANDARD | ANAESTHESIA CONDUCTION NEEDLE, SPINAL, SINGLE SHOT | BSP | PAJUNK GMBH MEDIZINTECHNOLOGIE | 021151-29A | 1275 | 14048223000257 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |