BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDLINE

    MDR report key: 24493022 · Received March 3, 2026

    Report

    Report Number
    3005670221-2026-00010
    Event Type
    Malfunction
    Date Received
    March 3, 2026
    Date of Event
    February 24, 2026
    Report Date
    March 3, 2026
    Manufacturer
    JIANGSU CAINA MEDICAL CO., LTD.
    Product Code
    FPA
    PMA / PMN Number
    K151991
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE RETURNED SAMPLES AND CORRECT LOT NUMBER OF THIS EVENT WAS REQUESTED BUT HASN'T BEEN RECEIVED TILL NOW, NO SAMPLE FOR EVALUATION AND NO DHR FOR REVIEW. THE ISSUE CAN'T BE CONFIRMED, THE ROOT CAUSE CAN'T DETECTED CURRENTLY. NO ACTION WILL BE TAKEN CURRENTLY, THIS ISSUE WILL BE MONITORED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF FURTHER INFORMATION RECEIVED.

    Description of Event or Problem · 0

    THE AMOUNT ON HAND IS STILL YET TO BE DETERMINED. THE LOT NUMBERS ARE 250401 FOR THE 21G AND 250601 FOR THE 23G. THESE ARE BUTTERFLIES THAT DO COME WITH THE PRE-ATTACHED HUB; PHLEBOTOMISTS ARE ASSEMBLING THE HUB MANUALLY. ACCORDING TO THE PHLEBOTOMIST THIS IS A GENERAL OBSERVATION ACROSS MULTIPLE LOTS. WE CAN DEFINITELY GET ON A CALL TO DISCUSS THIS. THE ISSUE OCCURRED DURING USE, BUT THERE IS NO INJURY. I DO NOT HAVE THE EXACT QUANTITY BUT WE STARTED WITH THIS NEEDLE SINCE DECEMBER AND OUR USAGE IS ROUGHLY 3 CASES A WEEK. WE RECEIVED REPORTS FROM SEVERAL OF OUR PHLEBOTOMISTS THAT THEIR PLACEMENT BUTTERFLY NEEDLES ARE DIFFICULT TO USE. THE PHLEBOTOMISTS SAID THAT AFTER THEY CONNECT THEN HOLDER AND BEGIN THE DRAW, THEY NOTICED THAT THE VACUTAINER TUBES DO NOT STAY VERY WELL IN THE HOLDER AND THAT THE BLOOD FLOW IS VERY SLOW. SOME SAID THAT THEY FEEL RESISTANCE FROM THE VACCUM AND TUBE WILL POP OUT FROM THE ASSEMBLY. THIS HAS LED TO MULTIPLE HEMOLYZED SPECIMENS AND/OR REDRAWS OF PATIENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    554198 MEDLINE SAFELOCK DISPOSABLE BLOOD COLLECTION SET FPA JIANGSU CAINA MEDICAL CO., LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other