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

Catalog Number	2C6931
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
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 received for evaluation; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
This report summarizes 1 malfunction events.It was reported that an unspecified amount of interlink continu-flo multi-port manifold sets disconnected after tightening.There was no patient injury or medical intervention associated with this event.No additional information is available.

• Brand Name: INTERLINK CONTINU-FLO MULTI-PORT MANIFOLD
• Common Device Name: STOPCOCK, I.V. SET
• Manufacturer (Section D): BAXTER HEALTHCARE - DOMINICAN REPUBLIC; haina san cristobal
• MDR Report Key: 8286669
• Report Number: 1416980-2019-00351
• Device Sequence Number: 1991805
• Product Code: FMG
• UDI-Device Identifier: 00085412035475
• UDI-Public: (01)00085412035475
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): Y
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/29/2019

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?: No
• Operator of Device: No Information
• Device Catalogue Number: 2C6931
• Device Lot Number: DR18C06027
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/31/2018
• Initial Report FDA Received Date: 01/29/2019
• Patient Sequence Number: 1