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

Catalog Number 5C4482S

Device Problems Fluid/Blood Leak (1250); Defective Component (2292)

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

Event Date 10/27/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that a minicap transfer set had fluid flow with the twist clamp closed.It was further reported that the transfer set line key does not allow the proper closing.This issue was identified during use of the device for peritoneal dialysis therapy.The transfer set was replaced.There was no patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

Additional information: d9, h3, h6, h10.H10: the sample was received for evaluation with a cap attached to the female connector.A visual inspection with the naked eye noted a damaged main body and broken occluder legs.The reported condition was verified.The cause of the leak was due to the damaged main body and occluder legs, however the cause of the damage 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
• Manufacturer (Section G): BAXTER HEALTHCARE - MOUNTAIN HOME; 1900 n highway 201; mountain home AR 72653
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL ; 2242702068
• MDR Report Key: 12860795
• MDR Text Key: 281157337
• Report Number: 1416980-2021-06931
• Device Sequence Number: 1
• Product Code: KDJ
• UDI-Device Identifier: 00085412476261
• UDI-Public: (01)00085412476261
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/23/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 5C4482S
• Device Lot Number: H21C31053
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/27/2021
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/03/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Sex: Male