FDA Adverse Event
Malfunction
Summary report: N
ACUTE PERITONEAL DIALYSIS SET
MDR report key: 8171697
·
Received December 17, 2018
Report
- Report Number
- 1820334-2018-03829
- Event Type
- Malfunction
- Date Received
- December 17, 2018
- Date of Event
- October 31, 2016
- Report Date
- December 17, 2018
- Manufacturer
- COOK VASCULAR INC
- Product Code
- KDJ
- UDI-DI
- 00827002052628
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- ES
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
COMMON NAME: CATHETER, PERITONEAL. PRODUCT CODE: GBW. THIS MDR IS BEING FILED AFTER THE ASSOCIATED COMPLAINT WAS REVIEWED UNDER REMEDIATION PROTOCOL (B)(4), COMPLAINT/MDR RETROSPECTIVE REVIEW AND REMEDIATION AND REASSESSED AS REPORTABLE. ADDITIONAL COMPLAINT INVESTIGATION AND RECORD REMEDIATION WAS NOT PERFORMED.
Description of Event or Problem · 1
IT WAS REPORTED THAT UPON OPENING OF THE PACKAGE, THE DIALYSIS SET WAS NOT IN GOOD CONDITION. IT WAS FURTHER NOTED THAT THE CAP WAS MISSING AND THE FLARE APPEARED FOLDED WHICH PREVENTED SEATING INTO THE BASE OF THE CAP. NO OTHER INFORMATION WAS MADE AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1011988 | ACUTE PERITONEAL DIALYSIS SET | KDJ | COOK VASCULAR INC | NA | NS7072030 | 00827002052628 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |