FDA Adverse Event
Injury
Summary report: N
INFILTRALONG SET
MDR report key: 8099226
·
Received November 23, 2018
Report
- Report Number
- 9611612-2018-00042
- Event Type
- Injury
- Date Received
- November 23, 2018
- Date of Event
- October 26, 2018
- Report Date
- December 21, 2018
- Manufacturer
- PAJUNK GMBH MEDIZINTECHNOLOGIE
- Product Code
- BSO
- UDI-DI
- 14048223016036
- PMA / PMN Number
- K080675
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- RISK MANAGER
Narratives
Additional Manufacturer Narrative · 0
EVENT TOOK PLACE IN THE UK AND HAS BEEN REPORTED THROUGH BRITISH DISTRIBUTION SUBSIDIARY PAJUNK MEDICAL LTD. BASED ON RISK ASSESSMENT AND CLINICAL ASSESSMENT THIS FILE IS CONSIDERED AS CLOSED. ATTACHMENT: [COMPLAINT REPORT FOR 414-18.PDF].
Description of Event or Problem · 0
IRN# (B)(4). CATHETER RUPTURED DURING REMOVAL. PIECE OF 20CM REMAINED IN PATIENT. HAD TO BE SURGICALLY REMOVED.
Additional Manufacturer Narrative · 1
EVENT TOOK PLACE IN THE (B)(6) AND HAS BEEN REPORTED THROUGH (B)(4) DISTRIBUTION SUBSIDIARY (B)(4). 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.
Description of Event or Problem · 1
(B)(4). CATHETER RUPTURED DURING REMOVAL. PIECE OF 20 CM REMAINED IN PATIENT. HAD TO BE SURGICALLY REMOVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 939098 | INFILTRALONG SET | ANALGESIA PROVIDING CATHETER, INFILTRATION | BSO | PAJUNK GMBH MEDIZINTECHNOLOGIE | 001158-10A | 1259 | 14048223016036 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |