BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® Z (NO ADDITIVE) PLUS URINE TUBE

    MDR report key: 8617467 · Received May 16, 2019

    Report

    Report Number
    9617032-2019-00600
    Event Type
    Malfunction
    Date Received
    May 16, 2019
    Date of Event
    April 29, 2019
    Report Date
    May 3, 2019
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    JSL
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). INVESTIGATION SUMMARY: BD HAD NOT RECEIVED SAMPLES, BUT PHOTOS WERE PROVIDED BY THE CUSTOMER FACILITY FOR INVESTIGATION. THE PHOTOS WERE EVALUATED AND THE CUSTOMER'S INDICATED FAILURE MODE FOR OVERFILL WITH THE INCIDENT LOT WAS NOT OBSERVED AS THE TUBE APPEARED TO BE EMPTY. ADDITIONALLY, RETENTION SAMPLES WERE SELECTED FROM BD INVENTORY FOR TESTING AND UPON COMPLETION, NO ISSUES WERE OBSERVED RELATING TO DRAW VOLUME AS ALL SAMPLES MET SPECIFICATIONS. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR THE INCIDENT LOT AND, BASED ON THIS REVIEW, ALL PRODUCT SPECIFICATIONS AND REQUIREMENTS FOR LOT RELEASE WERE MET; THERE WERE NO RELATED QUALITY NON-CONFORMANCES DURING MANUFACTURING OF THE PRODUCT. INVESTIGATION CONCLUSION: BASED ON EVALUATION OF THE RETENTION SAMPLES AND PHOTOS, THE CUSTOMER¿S INDICATED FAILURE MODE FOR OVERFILL WITH THE INCIDENT LOT WAS NOT OBSERVED AS ALL SAMPLES MET THE REQUIRED SPECIFICATIONS. ADDITIONALLY, THE PHOTOS DID NOT IDENTIFY A SPECIFIC PRODUCT ISSUE. ROOT CAUSE DESCRIPTION: BASED ON THE INVESTIGATION, A ROOT CAUSE COULD NOT BE DETERMINED. THE RETAIN PRODUCT WAS FOUND TO BE IN CONFORMANCE AND MEET RELEASE SPECIFICATIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT OVERFILL OCCURRED WITH A BD VACUTAINER® Z (NO ADDITIVE) PLUS URINE TUBE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "URINE TUBE 11 ML FILLS TOO MUCH AND ON THE TRACK OF ROCHE DEVICE THE URINE LEAK FROM THE TUBE AFTER OPENING OF THE TUBE." 200 OCCURRENCES WERE REPORTED, BUT THE DATE/TIME AND PATIENT INFORMATION IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    407926 BD VACUTAINER® Z (NO ADDITIVE) PLUS URINE TUBE TRANSPORT CULTURE MEDIUM JSL BECTON, DICKINSON AND COMPANY (BD) 9063852

    Patients

    Seq Age Sex Outcome Treatment
    1 Other