BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STOPCOCK MANIFOLD GANGS

    MDR report key: 10165267 · Received June 17, 2020

    Report

    Report Number
    1416980-2020-03424
    Event Type
    Malfunction
    Date Received
    June 17, 2020
    Date of Event
    May 26, 2020
    Report Date
    November 2, 2020
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FMG
    PMA / PMN Number
    K962581
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTIONS: B5,D1, D4 ,G5 (CATALOGUE #, BRAND NAME, 510K #). B5: THE AFFECTED PRODUCT IS ELCAM POLYCARBONATE THREE WAY STANDARD BORE, PREVIOUSLY SUBMITTED AS LARGE BORE STOPCOCK WITH ROTATING MALE LUER LOCK. D1: BRAND NAME: STOPCOCK REPLACED WITH STOPCOCK MANIFOLD GANGS. D4: CATALOGUE # 2C6204 REPLACED WITH 2C6240. G5: PMA/510K # K130245 REPLACED WITH K962581. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    CORRECTION TO D4: LOT # FROM URO8H20193 TO UR08H20193. H10: THE ACTUAL DEVICE WAS NOT AVAILABLE; HOWEVER, A PHOTOGRAPH OF THE SAMPLE WAS PROVIDED FOR EVALUATION.  VISUAL INSPECTION WAS PERFORMED TO THE PHOTOGRAPH USING THE NAKED EYE WHICH REVEALED A CRACK IN THE CENTER OF THE STOPCOCK. THE REPORTED CONDITION WAS VERIFIED. BY THE NATURE OF THE SAMPLE, NO ADDITIONAL TESTS WERE PERFORMED. THE CAUSE OF THE CONDITION COULD NOT BE DETERMINED. 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.

    Additional Manufacturer Narrative · 1

    SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A LARGE BORE STOPCOCK WAS CRACKED AND LEAKED DURING A CHEMOTHERAPY INFUSION. THE DEVICE WAS IN USE ON A PATIENT TO ADMINISTER GEMCITABINE (NON-BAXTER) WITH A FOLEY CATHETER. DURING THE INFUSION, THE NURSE NOTICED THE LEAK AND WRAPPED A GAUZE PAD AROUND IT AND WAS ABLE TO COMPLETE THE INFUSION WITH MINIMAL LEAKING. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    626339 STOPCOCK MANIFOLD GANGS STOPCOCK, I.V. SET FMG BAXTER HEALTHCARE CORPORATION NA URO8H20193

    Patients

    Seq Age Sex Outcome Treatment
    1 FOLEY CATHETER| GEMCITABINE