MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION CLEARLINK MULTI-PORT MANIFOLD; STOPCOCK, I.V. SET

Catalog Number 2C8921

Device Problems Material Deformation (2976); No Flow (2991)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The events occurred during the week of (b)(6) 2020.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that an unspecified quantity of clearlink system 3-port manifold sets would not flow.The event was further described as tubing would kink easily and would have to be taped in several places to keep it from kinking; the primary area of kinked tubing was on each end of the manifold.The kinked tubing also prevented needed medications of saline flush from fully being administered.This was identified during patient use.There was no report of 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.A visual inspection was performed to the photograph using the naked eye which did not identify any abnormalities that could have contributed to the reported condition.The reported condition is not clearly observed via the provided photograph and due to the nature of the returned sample no additional testing could be performed.Therefore, the reported event could not be objectively verified.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 MULTI-PORT MANIFOLD
• Type of Device: STOPCOCK, I.V. SET
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• MDR Report Key: 10515040
• MDR Text Key: 206360056
• Report Number: 1416980-2020-05587
• Device Sequence Number: 1
• Product Code: FMG
• UDI-Device Identifier: 00085412071718
• UDI-Public: (01)00085412071718
• Combination Product (y/n): Y
• PMA/PMN Number: K932512
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 10/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/10/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 2C8921
• Device Lot Number: DR20F20019
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SALINE FLUSH/MEDICATION; SALINE FLUSH/MEDICATION