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

Catalog Number T5C4326

Device Problems Device Slipped (1584); Connection Problem (2900)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/10/2014

Event Type  malfunction  

Event Description

It was reported that a uv flash transfer set would not connect properly with a titanium adapter.It became loose after being connected to the titanium adapter.There was no patient injury, medical intervention or adverse event associated with this event.No additional information is available.

Manufacturer Narrative

(b)(4).A request for the return of the device has been made.If additional relevant information is obtained, then a follow-up mdr will be submitted.

Manufacturer Narrative

(b)(4).A review of all batch record documents was performed for lot number h13i16036 with no issues noted during the manufacturing process.There were no deviations from standard procedure and no exceptions related to the reported condition noted.An evaluation of the actual sample was conducted.Visual inspection using a microscope, leak testing, clamp function testing and clear passage testing were performed with no issues noted.The integrity of the seal surface was tested with no leaks noted.The dimensional inspection of the returned transfer set sample found the diameter of the catheter connector/patient connector to be within specifications.The sample was not confirmed for the reported issue and a cause could not be determined as the device was found to be within product specifications.If additional relevant information is obtained, then a follow-up mdr will be submitted.

• Brand Name: UV FLASH TRANSFER SETS
• 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: christina arnt ; 25212 w. illinois route 120; round lake, IL 60073 ; 2242703198
• MDR Report Key: 3909387
• MDR Text Key: 4588040
• Report Number: 1416980-2014-21204
• Device Sequence Number: 1
• Product Code: KDJ
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/10/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 09/16/2018
• Device Catalogue Number: T5C4326
• Device Lot Number: H13I16036
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/30/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/16/2014
• 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
• Treatment: TITANIUM ADAPTER