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

Catalog Number T5C4326

Device Problem Bent (1059)

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

Event Date 07/11/2014

Event Type  malfunction  

Event Description

It was reported that a uv-flash solution transfer set was unable to connect to an extraneal 2 l solution bag (baxter product) due to a bent spike port.This occurred during patient use.There was no patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

(b)(4).(b)(6).The device was returned for evaluation.Leak testing, clear passage testing, and clamp function testing were performed with no issues noted.Visual and microscopic inspections were performed and found the device to have a bent spike and a damaged patient adapter.Should additional relevant information become available, a supplemental report will be submitted.

Manufacturer Narrative

(b)(4).The lot number of the device was unknown; therefore, a batch review could not be completed.Upon conclusion of the investigation, the cause of the event could not be determined.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: UV FLASH TRANSFER SETS
• Type of Device: SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
• Manufacturer (Section D): BAXTER HEALTHCARE - SINGAPORE; 2 woodlands industrial park; singapore 2573 ; SN 2573
• Manufacturer (Section G): BAXTER HEALTHCARE - SINGAPORE; 2 woodlands industrial park; singapore 2573 ; SN 2573
• Manufacturer Contact: christina arnt ; 25212 w. illinois route 120; round lake, IL 60073 ; 2242703198
• MDR Report Key: 3986377
• MDR Text Key: 4818153
• Report Number: 1416980-2014-25546
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date: 07/14/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/07/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: T5C4326
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/28/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/25/2014
• 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: EXTRANEAL J UV TWIN 2L BAG