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

Catalog Number R5C4482

Device Problem Material Integrity Problem (2978)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/20/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4) should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that the blue main body of a transfer set was damaged.There was no patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

(b)(4).The device was returned and an evaluation is complete.Visual inspection performed with naked eye and magnification noted damaged mainbody.Functional testing performed included leak testing, clear passage test, clamp function test, and integrity of seal surface test.The issue of damaged mainbody was verified, but the cause was not determined.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 - MOUNTAIN HOME; 1900 n highway 201; mountain home AR 72653
• Manufacturer (Section G): BAXTER HEALTHCARE - MOUNTAIN HOME; 1900 n highway 201; mountain home AR 72653
• Manufacturer Contact: kinga almasan ; 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 5435225
• MDR Text Key: 38172903
• Report Number: 1416980-2016-03251
• Device Sequence Number: 1
• Product Code: KDJ
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 03/31/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: R5C4482
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/11/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/29/2016
• 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: Unknown
• Patient Sequence Number: 1
• Patient Age: 68 YR