MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION MINICAP TRANSFER SET; SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

Catalog Number	5C4449
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event occurred on an unspecified date in (b)(6) 2020.Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that a minicap transfer set leaked from an unspecified location; further described as ¿somewhere along the transfer set, there was a slow leak.¿ this occurred when the patient flushed the catheter using a syringe filled with normal saline solution.The transfer set was replaced.There was no patient injury or medical intervention associated with this event.No additional information is available.
Additional Manufacturer Narrative
H10: the device was received for evaluation.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.A batch review was conducted, and there were no deviations found related to this reported condition, during the manufacture of this lot.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: MINICAP TRANSFER SET
• Common Device Name: SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• MDR Report Key: 11207532
• Report Number: 1416980-2020-08565
• Device Sequence Number: 17268796
• Product Code: KDJ
• UDI-Device Identifier: 00085412050867
• UDI-Public: (01)00085412050867
• Combination Product (Y/N): Y
• Initial Reporter Country: CA
• PMA/510(K) Number: K152675
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 02/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 05/21/2025
• Device Catalogue Number: 5C4449
• Device Lot Number: H20E21050
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/04/2021
• Initial Date Received by Manufacturer: 12/29/2020
• Supplement Date Received by Manufacturer: 02/22/2021
• Initial Report FDA Received Date: 01/21/2021
• Supplement Report FDA Received Date: 02/24/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1