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 Patient Involvement (2645)

Event Date 01/17/2015

Event Type  malfunction  

Event Description

It was reported that the tube of the transfer set was fractured.There was no patient involvement.No additional information is available.This is report 1 of 2.

Manufacturer Narrative

(b)(4).Should additional relevant information become available, a supplemental report will be submitted.Same patient/event as (b)(4).

Manufacturer Narrative

(b)(4).A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.An evaluation of the actual sample was completed.The visual inspection found that the sample was damaged at the light blue mainbody.The device passed the functional testing: leak testing, clamp function testing and clear passage testing.The reported event was verified through the sample evaluation; however, the cause could not be 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: 4578076
• MDR Text Key: 5482301
• Report Number: 1416980-2015-09516
• 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,Consumer,Company Representative
• Type of Report: Initial,Followup
• Report Date: 02/10/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 01/15/2019
• Device Catalogue Number: 5C4482
• Device Lot Number: H14A15026
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/18/2015
• Date Manufacturer Received: 05/22/2015
• 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