MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION EXTENSION SETS WITH ONE-LINK NEEDLE-FREE IV CONNECTOR; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number 7N8300

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

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

Event Date 01/10/2023

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the packaging (print side) of an unspecified quantity of one-link non-dehp microbore catheter extension sets were damaged; further described as "plastic breaking down and cracking".This was observed prior to use.The packaging was brittle and fell apart when touched.The sets were stored in plastic bins in a temperature-controlled area without any extreme temperatures.There was no patient involvement.No additional information is available.

Manufacturer Narrative

H10: the actual devices were not available; however, a photograph of samples was provided for evaluation.Visual inspection of the photograph identified the top web (lidding material) of the packaging was damaged/cracked.The reported condition was verified.The cause of damage could not be determined; however, a probable cause was prolonged exposure to inadequate storage conditions.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: EXTENSION SETS WITH ONE-LINK NEEDLE-FREE IV CONNECTOR
• 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: 16315372
• MDR Text Key: 309024863
• Report Number: 1416980-2023-00361
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 00085412091839
• UDI-Public: (01)00085412091839
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K132734
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 7N8300
• Device Lot Number: UR20B27039
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/03/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/28/2020
• 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