BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DISCARDIT II 5ML WITH 24X1

    MDR report key: 10168854 · Received June 18, 2020

    Report

    Report Number
    2243072-2020-00925
    Event Type
    Malfunction
    Date Received
    June 18, 2020
    Date of Event
    May 29, 2020
    Report Date
    June 4, 2020
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURING LOCATION FOR THIS PRODUCT IS (B)(4). THIS SITE IS NOT REGISTERED WITH THE FDA. THEREFORE, BD CORPORATE HEADQUARTERS IN (B)(4) HAS BEEN LISTED AND THE (B)(4) FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER. (B)(4). INVESTIGATION SUMMARY: PHOTOGRAPH RECEIVED AND AVAILABLE FOR INVESTIGATION. THE PHOTOGRAPHS AS WELL AS RETENTION SAMPLES WERE AVAILABLE FOR INVESTIGATION. THE TEAM INVESTIGATED THE PHOTOGRAPHS AND THE RETENTION SAMPLES OF MATERIAL NUMBER 300847 FOR LOT NUMBER 9191982. WHILE THE PHOTOGRAPH CONFIRMED THE CRACK ON THE BARREL WE DID NOT FIND ANY DEFECT IN THE RETENTION SAMPLES. THE DEFECT IS CONFIRMED ON THE PHOTOGRAPH RECEIVED. USED SAMPLES ARE NOT AVAILABLE AS THEY CAN`T KEEP IT AS PER THE POLICY. A COMPLAINT HISTORY CHECK WAS PERFORMED AND THIS IS THE 1ST RELATED COMPLAINT REPORTED WITH THE MATERIAL NUMBER 300847 FOR BATCH NUMBER 9191982. DHR REVIEWED FOUND NO NON-CONFORMITIES. INVESTIGATION CONCLUSION: COMPLAINTS RECEIVED FOR THIS DEVICE AND THE REPORTED DEFECT WILL CONTINUE TO BE TRACKED AND TRENDED. THE INFORMATION WILL BE CAPTURED IN THE TREND REPORTS AND MONITORED MONTHLY. COLLECTED DATA ARE REGULARLY REVIEWED TO IDENTIFY EMERGING TRENDS. ROOT CAUSE DESCRIPTION: STATION THAT CONTRIBUTE TO CRACK BARREL ARE BARREL LOADING- WE ARE MAKING PROCESS TO CHANGE BUSH OF BARREL LOADING BRACKET DURING. RATIONALE: CAPA IS NOT NEEDED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DISCARDIT II 5ML WITH 24X1 SYRINGE WAS CRACKED. THIS OCCURRED ON 15 OCCASIONS DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: BARREL OF THE SYRINGE CRACKED OPENED WHILE WITHDRAWING BLOOD, IT¿S A LAB FOR BIOTECHNOLOGY. SAME INCIDENT OCCURRED IN TWO LABS. THEY ARE USING OUR PRODUCT SINCE LONG TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    635902 DISCARDIT II 5ML WITH 24X1 SYRINGE FMF BECTON DICKINSON 9191982

    Patients

    Seq Age Sex Outcome Treatment
    1 Other