BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 50ML LL TIP 1ML

    MDR report key: 19613763 · Received June 26, 2024

    Report

    Report Number
    1911916-2024-00453
    Event Type
    Malfunction
    Date Received
    June 26, 2024
    Date of Event
    June 24, 2024
    Report Date
    June 30, 2024
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMF
    UDI-DI
    30382903096535
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    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 THERE WAS NO PRINTING ON THE SYRINGE. TO AID IN THE INVESTIGATION, ONE PHOTO WAS PROVIDED FOR EVALUATION BY OUR QUALITY TEAM. THE PHOTO SHOWS A SYRINGE WITH NO PACKAGING AND A SYRINGE BARREL THAT HAS NO VISIBLE PRINTED SCALE MARKING. NO OTHER DEFECTS OR IMPERFECTIONS WERE OBSERVED. THIS DEFECT COULD OCCUR IF THE PRINTING DRUM BECAME MISADJUSTED DURING THE PROCESSES. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 309653, LOT 4080219. 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 SYRINGE BARREL PRINTING PROCESS WAS PERFORMED. THE SETTINGS WERE CORRECT, AND 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 PHOTO SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER IS CONFIRMED.

    Description of Event or Problem · 0

    MATERIAL: 309653. BATCH#: 4080219. IT WAS REPORTED BY THE CUSTOMER THAT ARE RECEIVING REF # (B)(4) WITHOUT ANY MARKINGS ON THE SYRINGE. VERBATIM: WE ARE RECEIVING REF # (B)(4) WITHOUT ANY MARKINGS ON THE SYRINGE. SEE ATTACHED PICTURES. THIS ONE IS LOT #4080219.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION RECEIVED MATERIAL: 309653. BATCH#: 4080219. IT WAS REPORTED BY THE CUSTOMER THAT ARE RECEIVING REF #309653 WITHOUT ANY MARKINGS ON THE SYRINGE. VERBATIM: WE ARE RECEIVING REF #30965 WITHOUT ANY MARKINGS ON THE SYRINGE. SEE ATTACHED PICTURES. THIS ONE IS LOT #4080219. CUSTOMER RESPONSE: WE DON¿T HAVE ANY FURTHER PRODUCT TO HAVE RETURNED. STAFF WAS THROWING THESE AWAY BEFORE REPORTING THE ISSUE. WE ONLY HAD 2 REMAINING AT THE TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    679546 SYRINGE 50ML LL TIP 1ML SYRINGE, PISTON FMF BECTON DICKINSON 4080219 30382903096535

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown