BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN SYRINGE

    MDR report key: 19791743 · Received July 22, 2024

    Report

    Report Number
    2243072-2024-00816
    Event Type
    Malfunction
    Date Received
    July 22, 2024
    Date of Event
    June 1, 2024
    Report Date
    June 6, 2025
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMF
    UDI-DI
    30382903051107
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL MDR SUBMISSION WITH DEVICE EVALUATION. AS NO PHYSICAL SAMPLE, PICTURE SAMPLE, OR LOT NUMBER WAS PROVIDED FOR EVALUATION BY OUR QUALITY ENGINEER TEAM, A COMPLETE INVESTIGATION COULD NOT BE PERFORMED. THERE ARE CURRENT QUALITY CONTROLS IN PLACE TO DETECT THIS TYPE OF DEFECT DURING THE PRODUCTION PROCESS. BASED ON THE LIMITED INVESTIGATION RESULTS, A CAUSE FOR THE REPORTED INCIDENT COULD NOT BE DETERMINED. SHOULD YOU AGAIN EXPERIENCE ANY PROBLEMS WITH OUR PRODUCT WE WOULD APPRECIATE THE OPPORTUNITY TO CONDUCT A THOROUGH ANALYSIS. EXAMINATION OF THE PRODUCT INVOLVED MAY PROVIDE CLARIFICATION AS TO THE CAUSE FOR THE REPORTED FAILURE. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. OUR QUALITY TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Additional Manufacturer Narrative · 0

    (B)(4) CORRECTION: FOLLOWING THE SUBMISSION OF THE INITIAL MDR, IT HAS BEEN DETERMINED THAT THE PREVIOUSLY SUBMITTED REPORT WAS SENT IN ERROR, AND THE COMPLAINT WILL BE CANCELLED. THE ASSOCIATED MDR WILL BE VOID.

    Description of Event or Problem · 0

    MATERIAL#: 305110. BATCH NUMBER#: UNKNOWN. IT WAS REPORTED BY CUSTOMER THAT SYRINGE CRACKED AND INSULIN SPILLED OUT. VERBATIM#: RCC RECEIVED A COMPLAINT VIA EMAIL. 2) CALLER REPORTED [SYRINGE CRACKED AND INSULIN SPILLED OUT]. 3) WITH HOW MANY SYRINGES/NEEDLES DID THE CALLER EXPERIENCE THE ISSUE? - [RECORD NUMBER]. 4) DID ALL ISSUES OCCUR ON THE SAME DAY? ¿ NO. ISSUES OCCURRED: [WITHIN PAST MONTH OR SO]. 5) WAS THE SYRINGE/NEEDLE REUSED? - NO. 6) PRODUCT WITH ISSUE - BD 26 G, 3/8" NEEDLE, PN 305110. 7) IS PRODUCT AVAILABLE FOR RETURN TO BD? ¿ NO. 8) PRODUCT LOT # - UNAVAILABLE. 9) DID ISSUE CAUSE ANY INJURY? - NO. 11) HOW DID THE CUSTOMER RESOLVE THE ISSUE? ¿ CHANGED SYRINGE ONLY AND SUCCESSFULLY FILLED A CARTRIDGE WITH INSULIN. RESOLUTION ¿ NO FURTHER TANDEM FOLLOW UP IS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    738466 UNKNOWN SYRINGE SYRINGE, PISTON FMF BECTON DICKINSON UNKNOWN 30382903051107

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown