BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER URINE COMPLETE CUP KIT

    MDR report key: 11359367 · Received February 22, 2021

    Report

    Report Number
    1917413-2021-00109
    Event Type
    Malfunction
    Date Received
    February 22, 2021
    Date of Event
    January 29, 2021
    Report Date
    March 18, 2021
    Manufacturer
    BECTON, DICKINSON & CO. (BROKEN BOW)
    Product Code
    JSM
    PMA / PMN Number
    K024240
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.10. DEVICE AVAILABLE FOR EVAL?: YES. D.10. RETURNED TO MANUFACTURER ON: 2/19/2021. H.6. INVESTIGATION: NO CUSTOMER SAMPLES FROM CATALOG 364957, LOT NUMBER 0120087 WERE RETURNED FOR THIS COMPLAINT; HOWEVER, 2 CUSTOMER SAMPLES FROM CATALOG 364957, LOT NUMBER 0120087 WERE RETURNED FOR A RELATED COMPLAINT. NO PHOTOS WERE RETURNED TO BE EVALUATED. DRAW TESTING WAS PERFORMED AND ALL TUBES WERE WITHIN SPECIFICATION LIMITS. BD WAS UNABLE TO CONFIRM THE CUSTOMER¿S INDICATED FAILURE MODE BECAUSE THE DEFECT WAS NOT OBSERVED IN THE CUSTOMER SAMPLE TESTING. BASED ON THE INVESTIGATION RESULTS TO DATE, ROOT CAUSE WAS NOT DETERMINED. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® URINE COMPLETE CUP KIT THERE WAS UNDER-FILL OR LOW DRAW. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "THE TUBES WERE UNDERFILLING." RECEIVED CALL FROM LABORATORY MANAGER THAT REPORTS "FACILITY NOTICING .5 ML AWAY FROM MINIMUM FILL LINE. HE STATES ONLY 10 INSTANCES WITHIN A MONTHS TIME. NO SPECIFIC DATE OF EVENT. FACILITY HAS TO RECOLLECT PATIENT'S URINE WITH NO ISSUES. FACILITY IS SITTING AT 7,000 FEET ELEVATION."

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® URINE COMPLETE CUP KIT THERE WAS UNDER-FILL OR LOW DRAW. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "THE TUBES WERE UNDERFILLING." RECEIVED CALL FROM LABORATORY MANAGER THAT REPORTS "FACILITY NOTICING .5 ML AWAY FROM MINIMUM FILL LINE. HE STATES ONLY 10 INSTANCES WITHIN A MONTHS TIME. NO SPECIFIC DATE OF EVENT. FACILITY HAS TO RECOLLECT PATIENT'S URINE WITH NO ISSUES. FACILITY IS SITTING AT 7,000 FEET ELEVATION."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    256158 BD VACUTAINER URINE COMPLETE CUP KIT TRANSPORT CULTURE MEDIUM JSM BECTON, DICKINSON & CO. (BROKEN BOW) 0120087

    Patients

    Seq Age Sex Outcome Treatment
    1