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

Catalog Number 5C4482

Device Problems Fluid/Blood Leak (1250); Fitting Problem (2183)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

Initial reporter facility name: (b)(6).Initial reporter address:(b)(6).Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that a minicap transfer set had a connection issue; further described as "iodine leakage due to the mini cap could not tightly closed".This occurred at home during use of the devices for peritoneal dialysis therapy.There was no patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

H10: 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.

Manufacturer Narrative

Additional information: d9, h3, h6 and h10.H3: device returned for evaluation was changed from no to yes.H6: type of investigation was updated to include b01 for the actual sample received.Investigation findings was changed from c20 to c16 and investigation conclusions was changed from d15 to d0301.H10: the sample was received for evaluation with a mini cap attached to the female connector.A visual inspection with the naked eye and magnification noted a damaged female connector.Functional testing including clear passage and clamp function testing were performed with no issues noted.Leak testing failed due to a leak beneath the mini cap.The reported condition was verified.The cause of the leak is damage to the sealing surface of the female connector component where the mini cap mates to the female connector.The most probable cause of the female connector damage is handling of the part during the manufacturing process.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: MINICAP TRANSFER SET
• Type of Device: SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• MDR Report Key: 12066718
• MDR Text Key: 258361952
• Report Number: 1416980-2021-03907
• Device Sequence Number: 1
• Product Code: KDJ
• Combination Product (y/n): Y
• PMA/PMN Number: K152675
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 09/03/2021

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
• Device Operator: Lay User/Patient
• Device Catalogue Number: 5C4482
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/09/2021
• Initial Date Manufacturer Received: 06/01/2021
• Initial Date FDA Received: 06/25/2021
• Supplement Dates Manufacturer Received: 07/14/2021; 08/10/2021
• Supplement Dates FDA Received: 07/21/2021; 09/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: MINICAP.; MINICAP