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

Catalog Number 2N3348

Device Problem Material Split, Cut or Torn (4008)

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

Event Date 10/05/2023

Event Type  malfunction  

Event Description

It was reported that the tubing of a non-dehp micro-volume extension set was found in half.This was identified after opening the packaging.There was no patient involvement.No additional information is available.

Manufacturer Narrative

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

Manufacturer Narrative

H10: the device was received for evaluation.A visual inspection was performed using the naked eye and it was noted that the blister package was open; the sealing of the blister package between the top web and bottom web was not complete.Additionally the tubing of the set was observed to be damaged (cut).The reported condition was verified.The cause of the reported condition was a manufacturing issue; potentially caused by the package sealing machine.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: MICRO-VOLUME RADIATION STERILIZED EXTENSION SETS
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): BAXTER HEALTHCARE - AIBONITO; rd 721 km 0 3 po box 1389; aibonito 00705
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 18192377
• MDR Text Key: 328808691
• Report Number: 1416980-2023-06123
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 00085412004822
• UDI-Public: (01)00085412004822
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K811078
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/28/2023

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
• Device Operator: Other
• Device Catalogue Number: 2N3348
• Device Lot Number: UR23F09161
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/31/2023
• Initial Date FDA Received: 11/22/2023
• Supplement Dates Manufacturer Received: 12/27/2023
• Supplement Dates FDA Received: 12/28/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/13/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1