FDA Adverse Event
Malfunction
Summary report: N
SPROTTE 2.G
MDR report key: 8045400
·
Received November 7, 2018
Report
- Report Number
- 9611612-2018-00037
- Event Type
- Malfunction
- Date Received
- November 7, 2018
- Date of Event
- October 19, 2018
- Report Date
- December 14, 2018
- Manufacturer
- PAJUNK GMBH MEDIZINTECHNOLOGIE
- Product Code
- BSP
- UDI-DI
- 14048223024376
- PMA / PMN Number
- K911202
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
EVENT TOOK PLACE IN GERMANY AND HAS BEEN REPORTED THROUGH GERMAN DISTRIBUTION SUBSIDIARY PAJUNK MEDICAL PRODUKTE GMBH. BASED ON RISK MANAGEMENT FILE AND CLINICAL EVALUATION REPORT FILE IS CONSIDERED AS CLOSED. - ATTACHMENT: [COMPLAINT REPORT FOR 389-18.PDF].
Description of Event or Problem · 0
IRN# 591_389-18 . SUMMARIZING TRANSLATION OF INITIAL REPORTER´S NARRATIVE: CANNULA GOT LOOSENED FROM HUB.
Additional Manufacturer Narrative · 1
EVENT TOOK PLACE IN (B)(6) AND HAS BEEN REPORTED THROUGH (B)(4) 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
IRN# (B)(4). SUMMARIZING TRANSLATION OF INITIAL REPORTER´S NARRATIVE: CANNULA GOT LOOSENED FROM HUB.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 887819 | SPROTTE 2.G | ANAESTHESIA CONDUCTING NEEDLE, SPINAL, SINGLE SHOT | BSP | PAJUNK GMBH MEDIZINTECHNOLOGIE | 121251-30A | 1237 | 14048223024376 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |