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

Catalog Number 7N8399

Device Problems Fluid/Blood Leak (1250); Incomplete or Inadequate Connection (4037)

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

Event Type  malfunction  

Event Description

It was reported that an unspecified quantity of one-link needle-free iv connectors had connection issues with syringes resulting in radioactive isotope leakage; the connections were not stable.This was identified during unspecified process steps.The threads of the devices did not match up with a firm connection.Decontamination and replacement of the isotope was performed to continue treatments.There was no report of patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

The events occurred on unspecified dates, including "last week".The devices were not returned and the lot number is unknown; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.

Manufacturer Narrative

Additional information: d10, h10.D10: update "syringes" to "cardinal syringes".H10: should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: ONE-LINK NEUTRAL LUER ACTIVATED DEVICE
• 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: 12913492
• MDR Text Key: 282783063
• Report Number: 1416980-2021-07077
• Device Sequence Number: 1
• Product Code: FPA
• 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: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/29/2021

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: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/05/2021
• Initial Date FDA Received: 12/01/2021
• Supplement Dates Manufacturer Received: 12/03/2021
• Supplement Dates FDA Received: 12/29/2021
• 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
• Treatment: RADIOACTIVE ISOTOPE FLUID.; SYRINGES.