BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD DISCARDIT II SYRINGE

    MDR report key: 12562686 · Received October 1, 2021

    Report

    Report Number
    2243072-2021-02436
    Event Type
    Malfunction
    Date Received
    October 1, 2021
    Date of Event
    September 3, 2021
    Report Date
    September 15, 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

    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. INVESTIGATION SUMMARY: THE PHOTOS WERE RECEIVED BY BD FOR EVALUATION. A QUALITY ENGINEER WAS ABLE TO REVIEW THE PHOTO OF A DISCARDITII 2ML WITH 24*1 ((B)(4))FROM LOT # 1170870 REGARDING ITEM # 300844 WITH THE REPORTED ISSUE THAT THE ¿DISCARDIT 2ML WITH 24 G & 5ML WITH 24G NEEDLE HAVING ISSUES IN BLOOD WITHDRAWAL. AFTER .1 OR.2ML, THE SYRINGES ARE FAILING TO ASPIRATE THE BLOOD AND IT TAKES AIR INSIDE¿. THE DHR OF MATERIAL NUMBER 300844 AND LOT NUMBER 1170870 WAS CHECKED AND NO QUALITY NOTIFICATION WAS RECORDED ON THIS LOT. NO SAMPLES AND FOUR PHOTOGRAPHS 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 1170870 FOR INVESTIGATING THE REPORTED DEFECT. NONE OF THE TEN RETENTION SAMPLES USED FOR INVESTIGATION SHOWED ANY SYRINGE FAILING TO ASPIRATE THE BLOOD AND IT IS TAKING AIR INSIDE. AS ONLY FOUR PHOTOGRAPHS AVAILABLE FOR INVESTIGATION THE DEFECT CANNOT BE CONFIRMED. A SIMULATION OF THE DEFECT WAS PERFORMED ON THE RETENTION SAMPLE BY DAMAGING THEM IN DIFFERENT AREAS AND WAYS TO CONFIRM THE DEFECT. THE SIMULATION FAILED TO CONFIRM THE REPORTED DEFECT. THE DEFECT CANNOT BE CONFIRMED. THE PROBABLE ROOT CAUSE COULD BE THE USE OF A DIFFERENT NEEDLE OTHER THAN THE ONE PROVIDED ALONG WITH THE SYRINGE. A DIFFERENT NEEDLE HUB MAY HAVE A DIFFERENT FITMENT THAT COULD LEAD TO THIS DEFECT. BUT TO CONFIRM THE ASPIRATION DIFFICULTY AND AIR SUCTION THE INVESTIGATING TEAM REQUIRES THE ORIGINAL SAMPLE. 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 THE ABOVE, NO ADDITIONAL INVESTIGATION AND NO CAPA IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THE BD DISCARDIT¿ II SYRINGES HAD AIR BUBBLES FOAMING IN THE BLOOD WHILE WITHDRAWING IT. THIS OCCURRED WITH 25 SYRINGES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "DISCARDIT 2ML WITH 24 G & 5ML WITH 24G NEEDLE HAVING ISSUES IN BLOOD WITHDRAWAL. AFTER .1 OR.2ML, THE SYRINGES ARE FAILING TO ASPIRATE THE BLOOD AND IT TAKES AIR INSIDE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1457475 BD DISCARDIT II SYRINGE PISTON SYRINGE FMF BECTON DICKINSON 1170870

    Patients

    Seq Age Sex Outcome Treatment
    1