MINICAP
Report
- Report Number
- 1416980-2024-06111
- Event Type
- Malfunction
- Date Received
- October 28, 2024
- Date of Event
- September 27, 2024
- Report Date
- November 26, 2024
- Manufacturer
- BAXTER INTERNATIONAL INC.
- Product Code
- KDJ
- PMA / PMN Number
- K152675
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- NURSE
- Health Professional
- Yes
Narratives
H11: THE DEVICE WAS NOT RETURNED AND THE LOT NUMBER IS UNKNOWN; THEREFORE, A DEVICE ANALYSIS COULD NOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
CORRECTION MADE TO D1: BRAND NAME: NI (PREVIOUSLY SUBMITTED AS MINICAP). CORRECTION MADE TO D4: CATALOGUE #: ASKU (PREVIOUSLY SUBMITTED AS 5C4482). CORRECTION MADE TO D4: UNIQUE IDENTIFIER (UDI) #: NI (PREVIOUSLY SUBMITTED AS (B)(4)). CORRECTION MADE TO G4: PMA/510K # OR BLA #: NI (PREVIOUSLY SUBMITTED AS K152675. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
D4: THE LOT NUMBER IS UNKNOWN, THEREFORE, ONLY A PRIMARY DI NUMBER COULD BE PROVIDED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
IT WAS REPORTED THAT THE TWIST CLAMP OF THE MINICAP TRANSFER SET WAS BROKEN WHICH RESULTED IN A LEAK. 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 |
|---|---|---|---|---|---|---|---|
| 1781614 | MINICAP | SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE | KDJ | BAXTER INTERNATIONAL INC. | NA | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |