BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® Z (NO ADDITIVE) URINE TUBE

    MDR report key: 12844869 · Received November 19, 2021

    Report

    Report Number
    1917413-2021-00982
    Event Type
    Malfunction
    Date Received
    November 19, 2021
    Date of Event
    October 25, 2021
    Report Date
    January 24, 2022
    Manufacturer
    BECTON, DICKINSON & CO. (BROKEN BOW)
    Product Code
    JSL
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL? YES. D10: RETURNED TO MANUFACTURER ON: 2021-11-17. H6: INVESTIGATION SUMMARY BD RECEIVED THIRTY-FIVE (35) SAMPLES FOR INVESTIGATION. THE SAMPLES WERE EVALUATED BY VISUAL EXAMINATION AND SOME STOPPERS APPEARED TO HAVE A PUNCTURE MARK. TEN (10) OF THE SAMPLES WERE EVALUATED BY FUNCTIONAL DRAW TESTING AND THE INDICATED FAILURE MODE FOR UNDERFILL WITH THE INCIDENT LOT WAS OBSERVED. ADDITIONALLY, TEN (10) RETENTION SAMPLES FROM BD INVENTORY WERE EVALUATED BY FUNCTIONAL DRAW TESTING AND THE ISSUE OF UNDERFILL WAS NOT OBSERVED, AS ALL TUBES WERE WITHIN SPECIFICATION LIMITS. 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 NOTIFICATIONS. THIS COMPLAINT HAS BEEN CONFIRMED FOR THE INDICATED FAILURE MODE OF UNDERFILL BASED ON THE RETURNED SAMPLE TESTING; HOWEVER, A PUNCTURE MARK IN THE STOPPERS WAS OBSERVED IN SOME OF THE SAMPLES. BD WAS NOT ABLE TO IDENTIFY A ROOT CAUSE FOR THE INDICATED FAILURE MODE.

    Additional Manufacturer Narrative · 0

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® Z (NO ADDITIVE) URINE TUBE THERE WAS UNDER-FILL OR LOW DRAW OF A TUBE WITH BLOOD. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "THE TUBES CONTAIN TOO LITTLE VACUUM TO PULL THE LIQUIDS OUT OF THE MIXING CUPS."

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® Z (NO ADDITIVE) URINE TUBE THERE WAS UNDER-FILL OR LOW DRAW OF A TUBE WITH BLOOD. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "THE TUBES CONTAIN TOO LITTLE VACUUM TO PULL THE LIQUIDS OUT OF THE MIXING CUPS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1746737 BD VACUTAINER® Z (NO ADDITIVE) URINE TUBE TRANSPORT CULTURE MEDIUM JSL BECTON, DICKINSON & CO. (BROKEN BOW) 1137339

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown