BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SLIP-TIP SYRINGE WITH ATTACHED NEEDLE

    MDR report key: 10737907 · Received October 26, 2020

    Report

    Report Number
    1213809-2020-00738
    Event Type
    Malfunction
    Date Received
    October 26, 2020
    Date of Event
    September 4, 2020
    Report Date
    October 9, 2020
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903095972
    PMA / PMN Number
    K980580
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 8092876, MEDICAL DEVICE EXPIRATION DATE: 2023-03-31, DEVICE MANUFACTURE DATE: 2018-04-02. MEDICAL DEVICE LOT #: 9347549, MEDICAL DEVICE EXPIRATION DATE: 2024-11-30, DEVICE MANUFACTURE DATE: 2019-12-13. (B)(4). INVESTIGATION SUMMARY: NO PHOTOS OR SAMPLES WERE RECEIVED BY OUR QUALITY TEAM FOR EVALUATION THEREFORE THE FAILURE MODE COULD NOT BE VERIFIED. A REVIEW OF THE INTERNAL MANUFACTURING DEVICE RECORDS AND RAW MATERIAL HISTORY FILES FOR THE REPORTED LOT NUMBER WAS PERFORMED AND NO RECORDED QUALITY PROBLEMS OR REJECTIONS TO THIS INCIDENT WERE FOUND. BASED ON THE QUALITY TEAM'S INVESTIGATION, THE ROOT CAUSE OF THIS INCIDENT CANNOT BE DETERMINED. INVESTIGATION CONCLUSION: NO PHOTOS OR SAMPLES WERE RECEIVED FOR EVALUATION. ROOT CAUSE DESCRIPTION: SINCE NO SAMPLES DISPLAYING THE REPORTED CONDITION WERE RECEIVED A POTENTIAL ROOT CAUSE COULD NOT BE DEFINED. RATIONALE: SINCE NO SAMPLES DISPLAYING THE REPORTED CONDITION WERE RECEIVED CORRECTIVE ACTIONS ARE NOT NECESSARY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 4 BD¿ SLIP-TIP SYRINGES WITH ATTACHED NEEDLE FROM LOT 8092876, AND 4 SYRINGES FROM LOT 9347549 WERE UNABLE TO DRAW UP MEDICATION BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "PT STATED 8-INJECTION NEEDLES DID NOT WORK, UNABLE TO DRAW UP MEDICATION."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1203292 BD SLIP-TIP SYRINGE WITH ATTACHED NEEDLE PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 309597 SEE SECTION H.10. 30382903095972

    Patients

    Seq Age Sex Outcome Treatment
    1