BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD DISCARDIT¿ II SYRINGE

    MDR report key: 12869799 · Received November 24, 2021

    Report

    Report Number
    2243072-2021-02816
    Event Type
    Malfunction
    Date Received
    November 24, 2021
    Date of Event
    October 30, 2021
    Report Date
    November 11, 2021
    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
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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. INVESTIGATION SUMMARY: THE PHOTO WAS RECEIVED BY BD FOR EVALUATION. A QUALITY ENGINEER WAS ABLE TO REVIEW THE PHOTO OF A DISCARDIT 5ML FROM LOT # 1220332 REGARDING ITEM # 300850 WITH THE REPORTED ISSUE OF ¿CRACK IN THE BARREL WHILE WITHDRAWING BLOOD VIA CANNULA¿. THE DHR OF MATERIAL NUMBER 300850 AND LOT NUMBER 1220332 WAS CHECKED AND NO QUALITY NOTIFICATIONS WERE RECORDED ON THIS LOT. NO SAMPLES AND ONE PHOTOGRAPH WERE RECEIVED FROM THE CUSTOMER AND WERE USED FOR INVESTIGATION OF THE REPORTED DEFECTS. THE INVESTIGATION TEAM ALSO USED RETENTION SAMPLES OF MATERIAL CODE 300850 AND LOT NUMBER 1220332 FOR INVESTIGATING THE REPORTED DEFECT. NONE OF THE TEN RETENTION SAMPLES SHOWED ANY CRACK BARREL ON VISUAL INSPECTION. THE RECEIVED PHOTOGRAPH WAS INVESTIGATED FOR THE REPORTED DEFECT OF CRACK BARREL. THE PHOTOGRAPH CONFIRMED THE DEFECT ON VISUAL INSPECTION. THE DEFECT IS CONFIRMED. THE PROBABLE ROOT CAUSE OF CRACK BARREL IS DUE TO THE PROCESS OF 2ML ONLINE BARREL TRANSFER FROM MOLDING AREA TO THE HOPPER THAT PROCESSES THEM FURTHER TO ASSEMBLY AND PACKAGING. THE CRACKING OF THE BARREL WAS OBSERVED WHILE SIMULATING THIS PROCESS. IT WAS FOUND THAT WHEN COLD BARRELS (STORED IN POLY) ARE MIXED ALONG WITH ONLINE BARRELS, THERE IS A TEMPERATURE VARIATION OF HOT AND COLD BARRELS AS THEY ARE PASSING THROUGH THE PNEUMATIC SHOOT. AS A CORRECTIVE ACTION THE FOLLOWING TWO STEPS HAVE BEEN TAKEN: THE TEMPERATURE VARIATION CAUSING THE FREQUENT CHANGING OF PNEUMATIC PRESSURE SILO WILL BE FIXED HAVING CAPACITY OF APPROX. 70000 SYRINGES. THIS SILO WILL STORE THE MATERIAL BEFORE TRANSFERRING TO MACHINE, THIS WILL NOW ENSURE THAT THE BARRELS WILL ALL HAVE A UNIFORM COLD TEMPERATURE WHEN ITS MOVING IN THE PNEUMATIC SHOOT TOWARDS THE MACHINE. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. BASED ON THE ABOVE, NO ADDITIONAL INVESTIGATION AND NO CAPA IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 3 BD DISCARDIT¿ II SYRINGES HAD CRACKED BARRELS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "5ML DISCARDIT SYRINGE HAS DEVELOPED A CRACK IN THE BARREL WHILE WITHDRAWING BLOOD VIA CANNULA."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1766627 BD DISCARDIT¿ II SYRINGE PISTON SYRINGE FMF BECTON DICKINSON 1220332

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown