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

Catalog Number 2N1333

Device Problem Tear, Rip or Hole in Device Packaging (2385)

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

Event Date 06/06/2022

Event Type  malfunction  

Event Description

It was reported that one hundred sixteen non-dehp standard bore catheter extension sets were defective; further described as the packaging was falling apart in pieces (deteriorated).The issue was identified before use.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

A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.The devices were not received for evaluation; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: 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 ; 2242702068
• MDR Report Key: 14876457
• MDR Text Key: 295956497
• Report Number: 1416980-2022-03420
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K132734
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 08/02/2022

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: 2N1333
• Device Lot Number: UR16D20127
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/07/2022
• Initial Date FDA Received: 06/30/2022
• Supplement Dates Manufacturer Received: 07/27/2022
• Supplement Dates FDA Received: 08/02/2022
• Date Device Manufactured: 04/21/2016
• 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