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

Catalog Number 7N8399

Device Problem Disconnection (1171)

Patient Problem Hypoglycemia (1912)

Event Date 04/28/2021

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that during a pediatric patient infusion of total parenteral nutrition (tpn) with a one-link needle free connector, a disconnection was found.The event was further specified as the large volume tpn tubing was disconnected from the one-link cap on the manifold.Subsequently, the patient experienced hypoglycemia.The patient received a d50w bolus for the event.The cause of the disconnection was not reported.Ivf replacement (tpn) tubing was requested.At the time of this report, the nurse reported the patient outcome as they believe that the bolus ¿fixed¿ the hypoglycemia (no further details).No additional information is available.

Manufacturer Narrative

Correction: b4/f8: date of this report in the initial mdr is being corrected from blank to 06/07/2021.

Manufacturer Narrative

The device was 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.

• Brand Name: ONE-LINK NEUTRAL LUER ACTIVATED DEVICE
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• MDR Report Key: 11952457
• MDR Text Key: 256191940
• Report Number: 1416980-2021-03430
• 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,health
• Type of Report: Initial,Followup,Followup
• Report Date: 08/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2021
• 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: ASKU
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/12/2021
• 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: NI.
• Patient Outcome(s): Required Intervention