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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAXTER HEALTHCARE - DOMINICAN REPUBLIC INTERLINK CONTINU-FLO MULTI-PORT MANIFOLD; STOPCOCK, I.V. SET
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BAXTER HEALTHCARE - DOMINICAN REPUBLIC INTERLINK CONTINU-FLO MULTI-PORT MANIFOLD; STOPCOCK, I.V. SET Back to Search Results
Catalog Number 2C6931
Medical Device Problem Code Connection Problem (2900)
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 malfunction events.It was reported that an unspecified amount of interlink continu-flo multi-port manifold sets had connection issues.The reporter stated that the manifold would not tighten onto the luer lock.There was no patient injury or medical intervention associated with this event.No additional information is available.
 
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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 Key8286694
Report Number1416980-2019-00352
Device Sequence Number14128576
Product Code FMG
UDI-Device Identifier00085412035475
UDI-Public(01)00085412035475
Combination Product (Y/N)N
Number of Events Summarized1
Summary Report (Y/N)N
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 Number2C6931
Device Lot NumberDR18C06027
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 12/31/2018
Initial Report FDA Received Date01/29/2019
Patient Sequence Number1
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