BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD DISCARDIT¿ II SYRINGE

    MDR report key: 12746387 · Received November 3, 2021

    Report

    Report Number
    2243072-2021-02653
    Event Type
    Malfunction
    Date Received
    November 3, 2021
    Date of Event
    August 19, 2021
    Report Date
    November 3, 2021
    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 (B)(4) FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER. INVESTIGATION SUMMARY: THE SAMPLE WAS RECEIVED BY BD FOR EVALUATION. A QUALITY ENGINEER WAS ABLE TO REVIEW THE RETURNED SAMPLE OF (1) DISCARDITII 2ML WITH 24*1 (B)(4) FROM LOT # 1030341 PRODUCT # 300844 WITH THE REPORTED ISSUE OF ¿SIGNIFICANT AMOUNT OF AIR ENTERS THE SYRINGE WHILE WITHDRAWING MEDICATION FROM VIALS¿. THE DHR OF MATERIAL NUMBER 300844 AND LOT NUMBER 1030341 WAS CHECKED AND NO QUALITY NOTIFICATIONS WERE RECORDED ON THIS LOT. ONE SAMPLE 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 300844 AND LOT NUMBER 1030341 FOR INVESTIGATING THE REPORTED DEFECT. THE ORIGINAL SAMPLE WAS INVESTIGATED AND FOUND THAT AIR ASPIRATION IS FROM BARREL MARKING GRADUATION AREA. ROOT CAUSE IS THE HIGH STAMPING PRESSURE. THIS STAMPING IS ADJUSTED MANUALLY BY OPERATOR AS PER REQUIREMENT. THE PRESSURE COULD HAVE GOTTEN HIGH DURING THIS LOT STAMPING WHICH DAMAGED THE SYRINGE THUS LEADING TO AIR ASPIRATING IN THE PRODUCT. AS A CORRECTIVE ACTION A BUBBLE TEST IS INTRODUCED TO THE OPERATORS TO BE PERFORMED DURING THE SETTING OF THE MARKING STATION. TRAINING PROVIDED TO ALL OPERATORS TO PERFORM BUBBLE TEST WHENEVER SETTING IS DONE IN MARKING STATION. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. IF SAMPLES ARE RECEIVED IN THE FUTURE THE COMPLAINT WILL BE REOPENED FOR FURTHER INVESTIGATION. BASED ON THIS, A CAPA IS NOT NEEDED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 3000 BD DISCARDIT¿ II SYRINGES HAD DAMAGED BARRELS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CUSTOMER REPORTED SIGNIFICANT AMOUNT OF AIR ENTERS THE SYRINGE WHILE WITHDRAWING MEDICATION FROM VIALS". VIA BD INVESTIGATION: "THE ORIGINAL SAMPLE WAS INVESTIGATED AND FOUND THAT AIR ASPIRATION IS FROM BARREL MARKING GRADUATION AREA. ROOT CAUSE IS THE HIGH STAMPING PRESSURE. THIS STAMPING IS ADJUSTED MANUALLY BY OPERATOR AS PER REQUIREMENT. THE PRESSURE COULD HAVE GOTTEN HIGH DURING THIS LOT STAMPING WHICH DAMAGED THE SYRINGE THUS LEADING TO AIR ASPIRATING IN THE PRODUCT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1644001 BD DISCARDIT¿ II SYRINGE PISTON SYRINGE FMF 1030341

    Patients

    Seq Age Sex Outcome Treatment
    1