MAUDE Adverse Event Report: BAXTER HEALTHCARE - HAINA, SAN CRISTOBAL MICRO-VOLUME EXTENSION SET; FILTER, INFUSION LINE

Catalog Number 2N3350

Device Problems Crack (1135); Fluid/Blood Leak (1250)

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

Event Type  malfunction  

Manufacturer Narrative

Complaint no: (b)(4).The device was not returned and the lot number is unknown; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that there was a leak from a crack near the filter of an access extension set.This occurred after 72 hours of infusion of total parenteral nutrition (tpn) while using a non-baxter pump.There was no report of patient injury or medical intervention associated with this event.No additional information is available.

• Brand Name: MICRO-VOLUME EXTENSION SET
• Type of Device: FILTER, INFUSION LINE
• Manufacturer (Section D): BAXTER HEALTHCARE - HAINA, SAN CRISTOBAL; parque industrial itabo, zona; haina ; DR
• Manufacturer (Section G): BAXTER HEALTHCARE - HAINA, SAN CRISTOBAL; parque industrial itabo, zona; haina ; DR
• Manufacturer Contact: kinga almasan ; 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 5514918
• MDR Text Key: 40835081
• Report Number: 1416980-2016-05703
• Device Sequence Number: 1
• Product Code: FPB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K113227
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 2N3350
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/25/2016
• 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