FDA Adverse Event
Injury
Summary report: N
SPROTTE SURETY NEEDLE
MDR report key: 3946466
·
Received July 11, 2014
Report
- Report Number
- 9611612-2014-00005
- Event Type
- Injury
- Date Received
- July 11, 2014
- Date of Event
- June 7, 2014
- Report Date
- July 11, 2014
- Manufacturer
- PAJUNK GMBH MEDIZINTECHNOLOGIE
- Product Code
- BSP
- PMA / PMN Number
- K911260
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
NO SPECIFIC CORRECTIVE ACTION DUE TO MITIGATIVE PREVENTION OF HAZARDS IS ASSIGNED TO THIS REPORT. A REVIEW OF THE RELEVANT DEVICE HISTORY RECORDS AND THE RAW MATERIAL HISTORY FILES DID NEITHER INDICATE RECORDED QUALITY PROBLEMS NOR REJECTIONS RELATED TO THIS INCIDENT. IF NO FURTHER INFORMATION IS BECOMING AVAILABLE, MFR CONSIDERED THIS FILE AS CLOSED.
Description of Event or Problem · 1
(B)(4). EVENT TOOK PLACE IN (B)(6) AND HAS BEEN REPORTED TO (B)(6). USER'S NARRATIVE FROM INITIAL REPORT: "A PORTION OF THE NEEDLE BROKE OFF IN THE PATIENTS BACK. SURGICAL REMOVAL OF BROKEN PORTION OF NEEDLE."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 406917 | SPROTTE SURETY NEEDLE | 868.5150 ANESTHESIA CONDUCTION NEEDLE | BSP | PAJUNK GMBH MEDIZINTECHNOLOGIE | 051152-29A | 1028 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |