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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAXTER HEALTHCARE - DOMINICAN REPUBLIC CLEARLINK CONTINU-FLO MULTI-PORT MANIFOLD; STOPCOCK, I.V. SET
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BAXTER HEALTHCARE - DOMINICAN REPUBLIC CLEARLINK CONTINU-FLO MULTI-PORT MANIFOLD; STOPCOCK, I.V. SET Back to Search Results
Catalog Number 2C8931
Medical Device Problem Code Connection Problem (2900)
Health Effect - Clinical Code No Patient Involvement (2645)
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 number of clearlink continu-flo solution sets experienced connection issues.The clear plastic piece on the end of the tubing which attaches to the patient would not twist to lock onto the luer lock.This occurred during an unspecified process step.It was not specified whether there was patient involvement.No additional information is available.
 
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Brand Name
CLEARLINK CONTINU-FLO MULTI-PORT MANIFOLD
Common Device Name
STOPCOCK, I.V. SET
Manufacturer (Section D)
BAXTER HEALTHCARE - DOMINICAN REPUBLIC
haina, san cristobal
MDR Report Key8547299
Report Number1416980-2019-02216
Device Sequence Number11195145
Product Code FMG
UDI-Device Identifier00085412071725
UDI-Public(01)00085412071725
Combination Product (Y/N)N
Number of Events Summarized1
Summary Report (Y/N)Y
Reporter Type Manufacturer
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 04/24/2019
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 Number2C8931
Device Lot NumberDR18H30042
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 03/31/2019
Initial Report FDA Received Date04/24/2019
Patient Sequence Number1
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