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

Catalog Number 2C8931

Device Problem Loose or Intermittent Connection (1371)

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

Event Date 06/09/2023

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that there was no inner valve on one of the ports of a clearlink system continu-flo solution set.The manifold connections came loose event after tightening.The issue occurred after priming.There was no patient involvement.No additional information is available.

Manufacturer Narrative

H10: the device was received for evaluation.Visual inspection was performed and the inner valve was observed missing.Under water pressure testing was performed and a leak was observed at the y-site.The reported condition was verified.The condition cause of the condition was due a supplier manufacturing issue.Should additional relevant information become available, a supplemental report will be submitted.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 MULTI-PORT MANIFOLD
• Type of Device: STOPCOCK, I.V. SET
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): BAXTER HEALTHCARE - DOMINICAN REPUBLIC; carretera sanchez km 18.5; parque industrial itabo, piisa; haina, san cristobal 91000 ; DR 91000
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 17249416
• MDR Text Key: 318345159
• Report Number: 1416980-2023-03307
• Device Sequence Number: 1
• Product Code: FMG
• UDI-Device Identifier: 00085412071725
• UDI-Public: (01)00085412071725
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K932512
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/07/2023

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: Other
• Device Catalogue Number: 2C8931
• Device Lot Number: DR22J11048
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/09/2023
• Initial Date FDA Received: 07/03/2023
• Supplement Dates Manufacturer Received: 08/28/2023
• Supplement Dates FDA Received: 09/07/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/13/2022
• 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.