FDA Adverse Event
Injury
Summary report: N
MINICAP TRANSFER SET
MDR report key: 3133432
·
Received May 29, 2013
Report
- Report Number
- 1416980-2013-13506
- Event Type
- Injury
- Date Received
- May 29, 2013
- Report Date
- May 3, 2013
- Manufacturer
- BAXTER HEALTHCARE - MOUNTAIN HOME
- Product Code
- KDJ
- PMA / PMN Number
- K882498
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). DATE OF ONSET REPORTED AS (B)(6) 2013. A BATCH REVIEW WAS CONDUCTED FOR THE POTENTIALLY ASSOCIATED LOT NUMBER GD893305 AND GD893586. NO EXCEPTIONS WERE OBSERVED THAT WERE RELATED TO THE REPORTED CONDITION. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. SAME PATIENT AS (B)(4).
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
THIS IS REPORT 2 OF 2. THIS IS A REPORT OF PERITONITIS IN A PATIENT COINCIDENT WITH DIANEAL THERAPY FOR PERITONEAL DIALYSIS (PD). ACTION TAKEN WITH DIANEAL THERAPY WAS NOT REPORTED. THE PATIENT WAS HOSPITALIZED FOR THE EVENT. THE CAUSE OF PERITONITIS WAS UNKNOWN. TREATMENT WAS NOT REPORTED. ON AN UNREPORTED DATE, A NEW CATHETER WAS PLACED. THE PATIENT WAS RECOVERING FROM THIS PERITONITIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 234222 | MINICAP TRANSFER SET | SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE | KDJ | BAXTER HEALTHCARE - MOUNTAIN HOME |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization | DIANEAL PD4 ULTRABAG |