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

Catalog Number 2N3350

Device Problems Fluid/Blood Leak (1250); Material Puncture/Hole (1504)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/10/2021

Event Type  malfunction  

Manufacturer Narrative

Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported a non-dehp micro-volume extension set leaked.It was further reported the leak was observed originating from ¿from the small hole located in the circular filter piece of the tube¿.The event occurred initially ¿after pushing a medication through tube¿; however, the set was ¿hooked the flush up to the tubing and programmed the pump¿.There was no report of patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

B5: upon further due diligence, it was reported the event occurred during patient use.H10: 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.

Manufacturer Narrative

Additional information was added to h6.Additional information for h10: based on further investigation, the most probable cause was determined to be related to the end user/methods exceeding the product pressure specifications of 45psi.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: MICRO-VOLUME EXTENSION SET
• Type of Device: FILTER, INFUSION LINE
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• MDR Report Key: 11311140
• MDR Text Key: 231399572
• Report Number: 1416980-2021-00536
• Device Sequence Number: 1
• Product Code: FPB
• Combination Product (y/n): Y
• PMA/PMN Number: K113227
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 07/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 2N3350
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNSPECIFIED INFUSION PUMP; UNSPECIFIED MEDICATION