BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TUBE SST PLH 13X100 5.0 PLBL GOLD BR

    MDR report key: 12236537 · Received July 28, 2021

    Report

    Report Number
    3003916417-2021-00187
    Event Type
    Malfunction
    Date Received
    July 28, 2021
    Date of Event
    June 22, 2021
    Report Date
    July 29, 2021
    Manufacturer
    BECTON DICKINSON IND. CIRURGICAS LTDA
    Product Code
    JKA
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: THE DEVICE HISTORY RECORDS WERE REVIEWED, THERE WERE NO RELATED QUALITY NOTIFICATIONS AND ALL PROCESS AND FINAL INSPECTIONS COMPLY WITH SPECIFICATION REQUIREMENTS .THERE WERE NO RELATED QUALITY NOTIFICATIONS DURING BATCH MANUFACTURING, BUT THE STOPPER FUNCTION DEFECT IS UNDER INVESTIGATION THROUGH QNS (B)(4) (SKU 360060) AND (B)(4) (SKU 360059). NO PHOTO OR SAMPLE RECEIVED FOR EVALUATION. 200 RETAIN SAMPLES FROM EACH BATCH WERE EVALUATED FOR VISUAL DEFECTS AND NO DEFECT WAS FOUND, IN ADDITION IT WAS TESTED 5 SAMPLES FOR THE BATCH 1051704 FOR DRAW VOLUME AND NO PROBLEMS WERE FOUND. BD WAS UNABLE TO CONFIRM THE CUSTOMER¿S INDICATED FAILURES BASED ON THE INFORMATION PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE TUBE SST PLH 13X100 5.0 PLBL GOLD BR, THE DEVICE EXPERIENCED STOPPER PULL OUT OF TUBE WHEN IN AN ANALYZER, UNDERFILL OR LOW DRAW OF A TUBE WITH BLOOD. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: IN THE FORM ATTACHED, IT STATES THAT THE BATCH # 1051704 WITH STOPPER POP OFF DURING CENTRIFUGATION. STOPPER IS HARD TO BE RECAPPED AFTER OPENED. AND THE VACUUM IS WEAK, IT HARDILY REACHES THE INDICATED MARK OF THE TUBE.

    Additional Manufacturer Narrative · 1

    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 · 1

    IT WAS REPORTED WHEN USING THE TUBE SST PLH 13X100 5.0 PLBL GOLD BR, THE DEVICE EXPERIENCED STOPPER PULL OUT OF TUBE WHEN IN AN ANALYZER, UNDERFILL OR LOW DRAW OF A TUBE WITH BLOOD. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: IN THE FORM ATTACHED, IT STATES THAT THE BATCH # 1051704 WITH STOPPER POP OFF DURING CENTRIFUGATION. STOPPER IS HARD TO BE RECAPPED AFTER OPENED. AND THE VACUUM IS WEAK, IT HARDILY REACHES THE INDICATED MARK OF THE TUBE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1139328 TUBE SST PLH 13X100 5.0 PLBL GOLD BR BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON DICKINSON IND. CIRURGICAS LTDA 1051704

    Patients

    Seq Age Sex Outcome Treatment
    1