BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 20ML LL S/C 48

    MDR report key: 19522047 · Received June 12, 2024

    Report

    Report Number
    1911916-2024-00419
    Event Type
    Malfunction
    Date Received
    June 12, 2024
    Date of Event
    June 3, 2024
    Report Date
    June 21, 2024
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMF
    UDI-DI
    30382903028307
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL MDR SUBMISSION. A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION, A DEVICE EVALUATION, OR A DEVICE HISTORY REVIEW IS COMPLETED.

    Additional Manufacturer Narrative · 0

    (B)(4) FOLLOW UP IT WAS REPORTED THE PLUNGER BROKE WHEN ASPIRATING AIR. AS A SAMPLE WAS NOT RETURNED, A THOROUGH SAMPLE EVALUATION COULD NOT BE PERFORMED. TO AID IN THE INVESTIGATION, ONE PHOTO AND TWO VIDEOS WERE PROVIDED FOR EVALUATION BY OUR QUALITY TEAM. THE MEDIA SHOWS A NEEDLE ASSEMBLED TO A SYRINGE THAT IS DRAWING UP A DRUG. WHEN PULLING THE PLUNGER ROD UP A DAMAGED PLUNGER ROD RIB IS OBSERVED. NO OTHER DEFECTS OR IMPERFECTIONS WERE OBSERVED. THIS DEFECT COULD OCCUR IF THERE WAS A JAM DURING THE ASSEMBLY PROCESS. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 302830, LOT 2242123. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION OF THIS LOT THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. THERE WERE NO RELATED QUALITY NOTIFICATIONS. ALL PROCESSES AND FINAL INSPECTIONS COMPLIED WITH SPECIFICATION REQUIREMENTS. VERIFICATION OF THE ASSEMBLY PROCESS WAS PERFORMED. THE ALIGNMENT OF THE RAILS AND CONVEYORS WAS CORRECT. THE FLOW OF PRODUCT WAS GOOD. TO DATE, THERE HAVE BEEN NO OTHER SIMILAR EVENTS REPORTED FOR THIS LOT. BASED ON THE INVESTIGATION AND WITH THE SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER IS CONFIRMED.

    Description of Event or Problem · 0

    NEW 20ML SYRINGE PLUNGER BROKE WHEN THE ASPIRATING AIR IN THE PHARMACY.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED IMPACTED LOT NO. 2242123, EXP: 31-08-2027 NEW 20ML SYRINGE PLUNGER BROKE WHEN THE ASPIRATING AIR IN THE PHARMACY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    188878 SYRINGE 20ML LL S/C 48 SYRINGE, PISTON FMF BECTON DICKINSON 2242123 30382903028307

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown