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 Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

This event occurred during the unspecified date of (b)(6) 2020 (also reported as "over the course of two days").Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported fifteen (15) clearlink system continu-flo solution sets would not connect.The defect was further described as "the end would not screw together".There was no patient involvement.No additional information is available.

Manufacturer Narrative

H10: one device was received for evaluation.Visual inspection did not identify any abnormalities that could have contributed to the reported condition.Functional testing, including pressure and clear passage testing was performed with no issues noted.During the luer lock collar verification, it was identified that the collar of the two piece luer lock was not able to turn.The reported condition was verified.The presence of solvent was due to a manufacturing issue.The remainder of the 14 devices were not received for evaluation; therefore, a device analysis could not be completed.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
• MDR Report Key: 10976814
• MDR Text Key: 220470439
• Report Number: 1416980-2020-07663
• Device Sequence Number: 1
• Product Code: FMG
• UDI-Device Identifier: 00085412071725
• UDI-Public: (01)00085412071725
• 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: 01/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 2C8931
• Device Lot Number: DR20H31079
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2020
• Date Manufacturer Received: 12/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1