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

Catalog Number	2C8931
Medical Device Problem Codes	Disconnection (1171); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/18/2017
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 a clearlink continu-flo solution set disconnected during infusion, leading to a blood leak.The amount of patient blood loss was unknown.There was no report of patient injury or medical intervention associated with this event.No additional information is available.
Additional Manufacturer Narrative
A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.The device was not returned; therefore, a device analysis could not be completed.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 - HAINA; haina, san cristobal
• MDR Report Key: 7187599
• Report Number: 1416980-2018-00107
• Device Sequence Number: 19279214
• Product Code: FMG
• UDI-Device Identifier: 00085412071725
• UDI-Public: (01)00085412071725
• Combination Product (Y/N): N
• Initial Reporter State: VT
• 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): 01/31/2018

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 Expiration Date: 11/15/2022
• Device Catalogue Number: 2C8931
• Device Lot Number: DR17K14026
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/21/2017
• Supplement Date Received by Manufacturer: 01/24/2018
• Initial Report FDA Received Date: 01/12/2018
• Supplement Report FDA Received Date: 01/31/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1