MAUDE Adverse Event Report: INTERLINK; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number 2N3378

Device Problems Backflow (1064); Fluid/Blood Leak (1250)

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

Event Date 07/14/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that an interlink system non-dehp i.V.Catheter extension set leaked.It was further reported, the leak was "at the point of attachment to the iv catheter hub".It was stated the device leaked blood and unspecified fluids; along with, backflow of blood.This issue was identified during patient infusion.There was no patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

Additional information was added to h4 and h10.H10: 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: INTERLINK
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• MDR Report Key: 12354711
• MDR Text Key: 267709063
• Report Number: 1416980-2021-05171
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 00085412004938
• UDI-Public: (01)00085412004938
• Combination Product (y/n): Y
• PMA/PMN Number: K925126
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 09/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 2N3378
• Device Lot Number: UR17L02052
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/21/2021
• Date Device Manufactured: 12/13/2017
• 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
• Treatment: BD INSYTE AUTOGUARD IV CATHETER; BD INSYTE AUTOGUARD IV CATHETER