MAUDE Adverse Event Report: CLEARLINK SOLUTION ADMINISTRATION SETS; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number 2H8671

Device Problems Break (1069); Fluid/Blood Leak (1250); Device Dislodged or Dislocated (2923)

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

Event Date 06/25/2021

Event Type  malfunction  

Manufacturer Narrative

The user facility submitted medwatch 0700220000-2021-8020 for this event.Device manufacturer address 1: (b)(6).Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that a clearlink system non-dehp extension set was defective.It was further reported that the tubing snapped or dislodged during priming.This issue resulted in a waste of a ¿small amount¿ of total parenteral nutrition (tpn) fluid.As a result, the tubing was disconnected from the tpn bag and a new tubing was connected to continue with the therapy.This occurred prior to connecting to the patient.There was no patient involvement.No additional information is available.

Manufacturer Narrative

Correction: b4/f8: date of this report in the initial mdr is being corrected from blank to 08/10/2021.

Manufacturer Narrative

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: CLEARLINK SOLUTION ADMINISTRATION SETS
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• MDR Report Key: 12302577
• MDR Text Key: 265882239
• Report Number: 1416980-2021-04918
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 00085412080956
• UDI-Public: (01)00085412080956
• Combination Product (y/n): Y
• PMA/PMN Number: K153158
• 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: 09/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 2H8671
• Device Lot Number: R21B10042
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/08/2021
• Date Device Manufactured: 02/11/2021
• 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: NA.