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

Catalog Number 2C8537

Device Problem Component Missing (2306)

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

Event Date 01/27/2021

Event Type  malfunction  

Manufacturer Narrative

Device manufacturer address 1: (b)(4).Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that the connecting end (luer) of two (2) clearlink system continu-flo solution sets were missing.This was identified during priming.There was no patient involvement.No additional information is available.

Manufacturer Narrative

H10: one actual device was received for evaluation.The other sample was not received and therefore, could not be evaluated.Visual inspection was performed using the naked eye which observed that the male luer was missing.Additional inspection observed a lack of solvent applied on the tubing.Dimensional testing was performed on the tubing and no issues observed.The reported condition was verified.The cause of the condition could not be determined; however, the potential causes were noted to be human error during the manual assembly step or improper performance from the solvent dispenser during the manufacturing process.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
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• MDR Report Key: 11378664
• MDR Text Key: 233749666
• Report Number: 1416980-2021-00869
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 02/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/25/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 2C8537
• Device Lot Number: R20J06128
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/01/2021
• Date Manufacturer Received: 04/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1