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

Catalog Number 5C4482

Device Problem Fracture (1260)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/13/2015

Event Type  malfunction  

Event Description

It was reported that the switch of a transfer set was fractured.The device was in use at the time of the reported issue.There was no patient injury or medical intervention associated with this event.Should additional relevant information become available, a supplemental report will be submitted.

Manufacturer Narrative

(b)(4).The actual device was not available; however, a photograph of the sample was provided for evaluation.Visual inspection of the photograph did not identify any abnormalities that could have contributed to the reported condition.The reported condition was not verified.Should additional relevant information become available, a supplemental report will be submitted.

Manufacturer Narrative

(b)(4).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: 4795452
• MDR Text Key: 5815981
• Report Number: 1416980-2015-22756
• Device Sequence Number: 1
• Product Code: KDJ
• Combination Product (y/n): N
• PMA/PMN Number: K882498
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Type of Report: Initial,Followup
• Report Date: 05/06/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 5C4482
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/02/2015
• Was Device Evaluated by Manufacturer?: No
• 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