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

Catalog Number 5C4483

Device Problem Material Separation (1562)

Patient Problem Peritonitis (2252)

Event Date 08/14/2021

Event Type  Injury  

Manufacturer Narrative

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

Event Description

A peritoneal dialysis (pd) patient experienced a separation at the distal portion of the transfer set from the luer lock.This was further specified as the disconnection occurred between the silicone tubing and the beige "adapter connector".The transfer set was changed.The event occurred during use ¿a couple of weeks ago¿.It was reported the patient presented to the emergency department as was diagnosed with peritonitis.The cause of the separation was not reported.It was not reported if the patient was hospitalized for the event.Treatment for the event was not reported.At the time of this report, the patient outcome was not reported.Action with pd therapy was not reported.No additional information is available.

Manufacturer Narrative

Additional information: d9, h3, h6, h10.One actual sample was received for evaluation.A visual inspection with the naked eye noted the patient adapter slipped back from the bushing/tubing.Functional testing including leak testing, clear passage testing and clamp function testing were performed with no issues noted.The reported condition was verified.The cause of the condition could not be determined.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
• Type of Device: SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• MDR Report Key: 12443017
• MDR Text Key: 270554531
• Report Number: 1416980-2021-05527
• Device Sequence Number: 1
• Product Code: KDJ
• UDI-Device Identifier: 00085412007748
• UDI-Public: (01)00085412007748
• Combination Product (y/n): Y
• PMA/PMN Number: K192705
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 5C4483
• Device Lot Number: H21B01116
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/24/2021
• Date Manufacturer Received: 10/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other