FDA Adverse Event
Malfunction
Summary report: N
MINICAP TRANSFER SET
MDR report key: 3942211
·
Received July 17, 2014
Report
- Report Number
- 1416980-2014-23063
- Event Type
- Malfunction
- Date Received
- July 17, 2014
- Report Date
- June 23, 2014
- Manufacturer
- BAXTER HEALTHCARE - MOUNTAIN HOME
- Product Code
- KDJ
- PMA / PMN Number
- K882498
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- LA, US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
(B)(4). (B)(6). AS THE SAMPLE WAS NOT RETURNED, A DEVICE ANALYSIS CANNOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP MDR WILL BE SUBMITTED.
Description of Event or Problem · 1
IT WAS REPORTED THAT A MINICAP TRANSFER SET LEAKED FROM THE WHITE ROLLER CLAMP. THIS OCCURRED WHILE USING DIANEAL SOLUTION AT 1.5% AND 2.5% STRENGTH. THE PATIENT WAS GIVEN A THREE DAY COURSE OF ANTIBIOTICS AS A PRECAUTION. THERE WAS NO PATIENT INJURY OR ADVERSE EVENT ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 419633 | MINICAP TRANSFER SET | SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE | KDJ | BAXTER HEALTHCARE - MOUNTAIN HOME |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | DIANEAL SOLUTION |