MAUDE Adverse Event Report: CLEARLINK CONTINU-FLO SOLUTION SET; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number 2C8537

Device Problems Fluid/Blood Leak (1250); Failure to Disconnect (2541)

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

Event Date 07/20/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(6).(b)(4).Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that the tubing of a clearlink system continu-flo solution set was breaking off in a non baxter extension set.It was further reported that when disconnecting, the male luer breaks off into the female luer of the non baxter extension set.This resulted in an isolyte leak and blood backing up in the intravenous (iv) line.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

H10: the actual device was not available; however, a photograph of the sample was provided for evaluation.  visual inspection was performed to the photograph using the naked eye which revealed that the male luer rigid component gets stuck into female luer connector of b braun filtered extension tubing.The reported condition was verified.  by the nature of the sample, no additional tests were performed.  the cause of the condition could not be determined.  a batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: CLEARLINK CONTINU-FLO SOLUTION SET
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• MDR Report Key: 12324423
• MDR Text Key: 266650318
• Report Number: 1416980-2021-05019
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 00085412048970
• UDI-Public: (01)00085412048970
• Combination Product (y/n): Y
• PMA/PMN Number: K961225
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 09/17/2021

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: Health Professional
• Device Catalogue Number: 2C8537
• Device Lot Number: R21D05048
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/21/2021
• Initial Date FDA Received: 08/16/2021
• Supplement Dates Manufacturer Received: 09/15/2021
• Supplement Dates FDA Received: 09/17/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/05/2021
• 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: BRAUN EXTENSION SET; ISOLYTE; BRAUN EXTENSION SET; ISOLYTE