BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2243072-2017-00238

    MDR report key: 7076239 · Received December 1, 2017

    Report

    Report Number
    2243072-2017-00238
    Event Type
    Malfunction
    Date Received
    December 1, 2017
    Date of Event
    June 2, 2016
    Report Date
    November 6, 2017
    PMA / PMN Number
    K991088
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. MEDICAL DEVICE LOT #: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. BD RECEIVED SAMPLES FROM THE CUSTOMER FACILITY FOR INVESTIGATION. THE SAMPLES WERE EVALUATED AND THE CUSTOMER'S INDICATED FAILURE MODE FOR BROKEN/CRACKED CAP CONNECTOR WITH THE INCIDENT LOT WAS OBSERVED. CONFIRMED. THE SENSOR WAS EXCHANGED WITH A NEW ONE. THE SENSOR PROGRAM WAS ALSO MODIFIED SO THE SENSOR MALFUNCTION WILL BE DETECTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CAP OF THE CONNECTOR OF THE BD VACUTAINER® SAFETY-LOK BLOOD COLLECTION SET WAS CRACKED AND BROKEN. NO INJURY OR MEDICAL INTERVENTION REPORTED.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other