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

Catalog Number	2C8931
Medical Device Problem Codes	Crack (1135); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	09/24/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that "the manifold on either end" of a clearlink system continu-flo solution set was "cracked, bent and not working".This was identified during priming.There was no patient involvement.No additional information is available.
Additional Manufacturer Narrative
The actual sample was received for evaluation.A visual inspection was performed, and it was noted that port of the manifold was bent and almost broken.The reported problem was verified during initial inspection.The cause of the condition was due to a manufacturing issue.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
• Common Device Name: STOPCOCK, I.V. SET
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• MDR Report Key: 9305882
• Report Number: 1416980-2019-06235
• Device Sequence Number: 19410865
• Product Code: FMG
• UDI-Device Identifier: 00085412071725
• UDI-Public: (01)00085412071725
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K932512
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/13/2019

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
• Operator of Device: Other
• Device Catalogue Number: 2C8931
• Device Lot Number: DR19D15033
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/04/2019
• Initial Date Received by Manufacturer: 10/16/2019
• Supplement Date Received by Manufacturer: 12/06/2019
• Initial Report FDA Received Date: 11/11/2019
• Supplement Report FDA Received Date: 12/13/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1