MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION INTRAVASCULAR EXTENSION SETS AND ACCESSORIES; FILTER, INFUSION LINE

Catalog Number 2N3382

Device Problem Crack (1135)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/30/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported a crack was observed on the collar of the tubing of a micro-volume extension set.The event occurred while the user was ¿screwing new med line onto manifold¿ of a patient¿s line.There was no report of patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

H10: the device was received for evaluation.Visual inspection did not identify any abnormalities that could have contributed to the reported condition.Functional testing was performed, including pressure and clear passage testing; and no blockage or leaks were observed.Furthermore, pull testing was completed with no separation detected.The reported condition was not verified.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: INTRAVASCULAR EXTENSION SETS AND ACCESSORIES
• Type of Device: FILTER, INFUSION LINE
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• MDR Report Key: 11776268
• MDR Text Key: 249041686
• Report Number: 1416980-2021-02657
• Device Sequence Number: 1
• Product Code: FPB
• Combination Product (y/n): Y
• PMA/PMN Number: K192366
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 06/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 2N3382
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/09/2021
• Date Manufacturer Received: 06/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1