BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1024879-2017-01085

    MDR report key: 7075791 · Received December 1, 2017

    Report

    Report Number
    1024879-2017-01085
    Event Type
    Malfunction
    Date Received
    December 1, 2017
    Date of Event
    April 13, 2017
    Report Date
    November 8, 2017
    PMA / PMN Number
    K030573
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. RESULTS: (B)(4) CUSTOMER SAMPLES WERE RETURNED AND TESTED UNDER PRESSURIZED CONDITIONS WITH NO LEAKAGE DEFECTS IDENTIFIED. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH 7051592 MANUFACTURED FEBRUARY 2017. ALL INSPECTIONS WERE IN COMPLIANCE WITH REQUIREMENTS. CONCLUSION: BASED ON THE INVESTIGATION, NO PRODUCT ISSUE WAS IDENTIFIED AS THE PRODUCT WAS FOUND TO BE IN CONFORMANCE AND MEET RELEASE SPECIFICATIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 23 G X .75 IN. BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET HAD 2 INSTANCES OF BLOOD LEAKAGE, 1 WITH EACH LOT #, 5140634 AND 7051592. THE LEAKAGE OCCURRED NEAR THE WINGSET END. NO INJURY OR MEDICAL INTERVENTION REPORTED.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other