MINICAP TRANSFER SET
Report
- Report Number
- 1416980-2023-06891
- Event Type
- Malfunction
- Date Received
- January 3, 2024
- Date of Event
- December 9, 2023
- Report Date
- February 6, 2024
- Manufacturer
- BAXTER HEALTHCARE CORPORATION
- Product Code
- KDJ
- PMA / PMN Number
- K152675
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- NURSE
- Health Professional
- Yes
Narratives
SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
UPDATE MADE TO D1: BRAND NAME: MINICAP TRANSFER SET (PREVIOUSLY SUBMITTED AS NI). UPDATE MADE TO D4: CATALOGUE #: 5C4482 (PREVIOUSLY SUBMITTED AS ASKU). UPDATE MADE TO G4: PMA/510K #: K152675 (PREVIOUSLY SUBMITTED AS NI) . THE DEVICE WAS RECEIVED FOR EVALUATION. A VISUAL INSPECTION DID NOT IDENTIFY ANY ABNORMALITIES THAT COULD HAVE CONTRIBUTED TO THE REPORTED CONDITION. FUNCTIONAL TESTING INCLUDING LEAK, CLEAR PASSAGE, AND CLAMP FUNCTION TESTING WERE PERFORMED WITH NO ISSUES NOTED. THE REPORTED CONDITION WAS NOT VERIFIED. THE DEVICE MET SPECIFICATION. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
IT WAS REPORTED THAT THERE WAS A SEPARATION BETWEEN THE FEMALE CONNECTOR (DARK BLUE) AND MAIN BODY (LIGHT BLUE) OF THE MINICAP TRANSFER SET. THIS WAS OBSERVED DURING USE OF THE DEVICE FOR PERITONEAL DIALYSIS THERAPY. THE TRANSFER SET WAS REPLACED. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 627494 | MINICAP TRANSFER SET | SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE | KDJ | BAXTER HEALTHCARE CORPORATION | NA | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Male |