FDA Adverse Event
Malfunction
Summary report: N
INTRODUCER OF SPROTTE
MDR report key: 6150237
·
Received December 7, 2016
Report
- Report Number
- 9611612-2016-00149
- Event Type
- Malfunction
- Date Received
- December 7, 2016
- Date of Event
- November 15, 2016
- Report Date
- March 7, 2017
- Manufacturer
- PAJUNK GMBH MEDIZINTECHNOLOGIE
- Product Code
- BSP
- UDI-DI
- 04048223002421
- PMA / PMN Number
- K911260
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
CURRENTLY THE DATA IS POOR AND THE DEVICE HAS NOT BEEN SENT BACK/ ANALYSED. AS SOON AS FURTHER DATA WILL BE AVAILABLE A FOLLOW UP REPORT WILL BE SENT IN TO THE AGENCY.
Additional Manufacturer Narrative · 1
BASED ON RISK ASSESSMENT AND CLINICAL EVALUATION FILE IS CONSIDERED AS CLOSED.
Description of Event or Problem · 1
(B)(4). SUMMARIZING TENTATIVE TRANSLATION FROM INITIAL REPORTER´S NARRATIVE: INTRODUCER OF SPINAL NEEDLE BROKE UPON PLACEMENT OF NEEDLE.
Description of Event or Problem · 1
(B)(4). SUMMARIZING TENTATIVE TRANSLATION FROM INITIAL REPORTER´S NARRATIVE: INTRODUCER OF SPINAL NEEDLE BROKE UPON PLACEMENT OF NEEDLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 801612 | INTRODUCER OF SPROTTE | PINAL ANAESTHESIA NEEDLE INTRODUCER | BSP | PAJUNK GMBH MEDIZINTECHNOLOGIE | 321151-31A | 1171 | 04048223002421 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |