MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION ONE-LINK NEUTRAL LUER ACTIVATED DEVICE; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number 7N8399

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

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

Event Date 07/12/2021

Event Type  malfunction  

Manufacturer Narrative

The actual devices were not available; however, two (2) companion sample were received for evaluation.Visual inspection was performed which observed a packaging-damaged sterile packaging.The reported condition was verified.The cause of the condition could not be determined.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.

Event Description

During evaluation two (2) one-link needle-free iv connectors were returned with damaged sterile packaging.This was observed prior to patient use.There was no patient involvement.No additional information is available.

• Brand Name: ONE-LINK NEUTRAL LUER ACTIVATED DEVICE
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• MDR Report Key: 12440021
• MDR Text Key: 270350539
• Report Number: 1416980-2021-05517
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): Y
• PMA/PMN Number: K132734
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial
• Report Date: 09/08/2021

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
• Device Operator: Other
• Device Catalogue Number: 7N8399
• Device Lot Number: UR17F15071
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/03/2021
• Initial Date FDA Received: 09/08/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/20/2017
• 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