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

Catalog Number 6AC4466

Device Problem Failure to Disconnect (2541)

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

Event Date 11/06/2022

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 was difficult to disconnect from the female connector of a peritoneal dialysis (pd) transfer set.This occurred during use of the devices for pd therapy.There was no report of patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

Correction made to b5: this condition would not likely result in a serious injury as there is no breach in the sterile pathway.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.

• Brand Name: MINICAP
• Type of Device: SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): BAXTER HEALTHCARE - GUANGZHOU; no. 6 jiao yuan road; dong ji industrial district; guangzhou 51073 0; CH 510730
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 15924847
• MDR Text Key: 305611340
• Report Number: 1416980-2022-06656
• Device Sequence Number: 1
• Product Code: KDJ
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 01/03/2023

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: 6AC4466
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/08/2022
• Initial Date FDA Received: 12/06/2022
• Supplement Dates Manufacturer Received: 12/15/2022
• Supplement Dates FDA Received: 01/03/2023
• 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
• Treatment: TRANSFER SET
• Patient Age: 33 YR
• Patient Sex: Female