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

Catalog Number 5C4482

Device Problems Material Separation (1562); Failure to Disconnect (2541)

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

Event Date 02/19/2021

Event Type  malfunction  

Manufacturer Narrative

Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that the "dark blue tip" (female connector) of a minicap extended life pd transfer set was damaged; further described as "dark blue tip loosening, making it difficult to disconnect from the patient line" of the cassette.Customer reported the dark blue tip never detached.This occurred during use for peritoneal dialysis (pd) therapy.As a result, the transfer set was removed and replaced.There was no patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

The sample was received for evaluation without a cap or patient connector.A visual inspection with the naked eye noted a female connector separated from the light blue main body.There was evidence on the female connector an insert chip was present and possibly dislodged during disconnection.Functional testing including leak, clear passage, and clamp function testing were performed with no issues noted.The connection between an in lab patient connector and the female connected was performed with no issue or leak observed.The reported condition of separation between the female connector and main body was verified, however the reported condition of damage and connection to female connector was not verified.The cause of the separation between the female connector and main body was due to inadequate solvent application to the main body during the manufacturing process.A nonconformance has been opened to address this issue.A batch review was conducted and there were no deviations found related to this condition during the manufacture of this lot.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: 11507460
• MDR Text Key: 241153945
• Report Number: 1416980-2021-01404
• Device Sequence Number: 1
• Product Code: KDJ
• UDI-Device Identifier: 00085412007731
• UDI-Public: (01)00085412007731
• 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,consum
• Type of Report: Initial,Followup
• Report Date: 04/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2021
• 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: H20K17057
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/05/2021
• Date Manufacturer Received: 04/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNSPECIFIED CASSETTE SET