MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION RADIATION STERILIZED EXTENSION SETS; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	2N3349
Medical Device Problem Codes	Crack (1135); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/10/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The user facility submitted medwatch (b)(4) for this event.Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that the tubing of a non-dehp high flow rate extension set had a small crack which led to a medication leak.This issue was identified during patient infusion.There was no report of patient injury or medical intervention associated with this event.No additional information is available.
Additional Manufacturer Narrative
The device was received for evaluation.Visual inspection was performed which observed a cut near microbore winged female luer lock adapter.Functional testing was performed including pressure testing and clear passage test which had satisfactory result in clear passage test; however, failed in pressure testing.The reported condition was verified.The most probable cause is user related.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: RADIATION STERILIZED EXTENSION SETS
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• MDR Report Key: 11487865
• Report Number: 1416980-2021-01329
• Device Sequence Number: 3412330
• Product Code: FPA
• UDI-Device Identifier: 00085412004839
• UDI-Public: (01)00085412004839
• Combination Product (Y/N): Y
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K811078
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 2N3349
• Device Lot Number: UR20H30014
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/11/2021
• Initial Date Received by Manufacturer: 02/18/2021
• Supplement Date Received by Manufacturer: 04/13/2021
• Initial Report FDA Received Date: 03/15/2021
• Supplement Report FDA Received Date: 04/14/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 1 MO
• Patient Weight: 4