FDA Adverse Event
Malfunction
Summary report: N
SPROTTE
MDR report key: 8045399
·
Received November 7, 2018
Report
- Report Number
- 9611612-2018-00038
- Event Type
- Malfunction
- Date Received
- November 7, 2018
- Date of Event
- October 22, 2018
- Report Date
- December 14, 2018
- Manufacturer
- PAJUNK GMBH MEDIZINTECHNOLOGIE
- Product Code
- BSP
- UDI-DI
- 14048223000844
- 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 AUSTRIA AND HAS BEEN REPORTED THROUGH GERMAN DISTRIBUTION SUBSIDIARY PAJUNK MEDICAL PRODUKTE GMBH. BASED ON RISK ASSESSMENT AND CLINICAL EVALUATION REPORT FILE IS CONSIDERED AS CLOSED. - ATTACHMENT: [COMPLAINT REPORT FOR 394-18.PDF].
Description of Event or Problem · 0
IRN# 596_394-18. 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 |
|---|---|---|---|---|---|---|---|
| 887816 | SPROTTE | ANAESTHESIA CONDUCTING NEEDLE, SPINAL, SINGLE SHOT | BSP | PAJUNK GMBH MEDIZINTECHNOLOGIE | 501151-29A | 1240 | 14048223000844 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |