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

Catalog Number 7N8399

Device Problem Fluid/Blood Leak (1250)

Patient Problem Injury (2348)

Event Date 01/15/2021

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that during patient infusion of pentobarbital with a one-link needlefree connector, the patient became agitated.It was reported a leak was observed from the connector ¿between the stopcock and the white heplock cap", further specified as the top of heplock cap.It was reported the nurse tried to tighten the connection and change the stopcock; however, the leak continued.The heplock cap was changed and the leak stopped.No disconnection or damage was noted to the device.The patient was administered "boluses of the medication" and the patient ¿settled down¿.No additional information is available.

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 device was 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: ONE-LINK NEUTRAL LUER ACTIVATED DEVICE
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• MDR Report Key: 11302705
• MDR Text Key: 231013443
• Report Number: 1416980-2021-00492
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 00085412091785
• UDI-Public: (01)00085412091785
• 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,health
• Type of Report: Initial,Followup
• Report Date: 03/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 7N8399
• Device Lot Number: UR20E31034
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SMITH MEDICAL 4-WAY STOPCOCK; SMITH MEDICAL 4-WAY STOPCOCK
• Patient Outcome(s): Required Intervention
• Patient Age: 29 MO