BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® ECLIPSE¿ SIGNAL¿ BLOOD COLLECTION NEEDLE WITH INTEGRATED HOLDER

    MDR report key: 17958532 · Received October 18, 2023

    Report

    Report Number
    9617032-2023-01484
    Event Type
    Malfunction
    Date Received
    October 18, 2023
    Date of Event
    September 27, 2023
    Report Date
    October 3, 2023
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    JKA
    UDI-DI
    30382903688358
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: D.4. MEDICAL DEVICE LOT #: 2271619; D.4. MEDICAL DEVICE EXPIRATION DATE: 31-OCT-2025; H.4. DEVICE MANUFACTURE DATE: 28-SEP-2022; D.4. MEDICAL DEVICE LOT #: 2243916; D.4. MEDICAL DEVICE EXPIRATION DATE: 31-AUG-2025; H.4. DEVICE MANUFACTURE DATE: 31-AUG-2022. H.6 INVESTIGATION SUMMARY: BD HAD NOT RECEIVED SAMPLES, BUT 1 PHOTO WAS PROVIDED FOR INVESTIGATION. THE PHOTO WAS REVIEWED AND THE INDICATED FAILURE MODE FOR HUB - HOLDER SEPARATION WAS OBSERVED. ADDITIONALLY, 10 RETENTION SAMPLES FROM BD INVENTORY WERE EVALUATED BY FUNCTIONAL TESTING, EACH USED TO DRAW 6 VACUTAINER TUBES, AND THE ISSUE OF HUB - HOLDER SEPARATION WAS NOT OBSERVED. BASED ON A REVIEW OF THE DEVICE HISTORY RECORD FOR THE INCIDENT LOT, ALL PRODUCT SPECIFICATIONS AND REQUIREMENTS FOR LOT RELEASE WERE MET. THERE WERE NO RELATED QUALITY ISSUES DURING MANUFACTURING OF THE PRODUCT. THIS COMPLAINT HAS BEEN CONFIRMED FOR THE INDICATED FAILURE MODE HUB - HOLDER SEPARATION. BD WAS NOT ABLE TO IDENTIFY A ROOT CAUSE FOR THE INDICATED FAILURE MODE. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE WITH 2 LOTS OF BD VACUTAINER® ECLIPSE¿ SIGNAL¿ BLOOD COLLECTION NEEDLE WITH INTEGRATED HOLDER THE HOLDER SEPARATED FROM THE DEVICE. PATIENT WAS BRUISED, NO OTHER IMPACT WAS REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: HOLDER DROPPED OFF; WHEN DID THE INCIDENT OCCUR? DURING USE; THE TECHNICIAN HAS SURVIVED THE SITUATION WITH A FRIGHT, BUT THE PATIENT HAS PROBABLY RECEIVED A SERIOUS BRUISE ON HIS HAND AS A RESULT OF SAMPLING. IT IS VERY LIKELY THAT THE NEEDLE HAS ALSO PUNCTURED THE BACK OF THE VEIN WHEN IT HAS DETACHED FROM THE SLEEVE DURING THE ILLEGAL USE OF THE TUBE. THE SAMPLER HAS MORE THAN 20 YEARS OF EXPERIENCE AND WAS FAMILIAR WITH THE PRODUCT. THE CUSTOMER STILL HAS THE NEEDLE IF YOU NEED IT FOR FURTHER EXAMINATIONS. "THEY CAN¿T NO WHICH LOT IT WAS . BOTH LOTS ARE NOW IN USE. PATIENT GOT A BIG BRUISE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203391 BD VACUTAINER® ECLIPSE¿ SIGNAL¿ BLOOD COLLECTION NEEDLE WITH INTEGRATED HOLDER BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON AND COMPANY (BD) SEE H.10 30382903688358

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown