BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 50ML LL TIP 1ML

    MDR report key: 20302718 · Received September 25, 2024

    Report

    Report Number
    1911916-2024-00698
    Event Type
    Malfunction
    Date Received
    September 25, 2024
    Date of Event
    September 24, 2024
    Report Date
    October 10, 2024
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMF
    UDI-DI
    30382903096535
    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

    (B)(4). FOLLOW UP. IT WAS REPORTED SYRINGES HAVE POOR QUALITY OF PRINTING ON THEM. AS A SAMPLE WAS NOT RETURNED, A THOROUGH SAMPLE EVALUATION COULD NOT BE PERFORMED. TO AID IN THE INVESTIGATION, THREE PHOTOS WERE PROVIDED FOR EVALUATION BY OUR QUALITY TEAM. ONE PHOTO SHOWS A PACKAGING BLISTER TOP WEB. THE OTHER TWO PHOTOS SHOW A SYRINGE BARREL WITH A SCALE MARKING THAT IS LEGIBLE AND ACCEPTABLE. NO DEFECTS WERE OBSERVED. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 309653, LOT 4143053. 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. 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 COULD NOT BE CONFIRMED.

    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.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED. THE CORRECT BATCH NUMBER 4143053. THE SYRINGES IN THE NEW LOTS HAVE POOR QUALITY OF PRINTING ON THEM, WITH THE NUMBERING FADED IN PLACES. WHILST THE NUMBERS ARE STILL LEGIBLE, THE FADING COULD LEAD OUR CUSTOMERS TO BELIEVE THAT THE SYRINGES ARE OF POORER QUALITY THAN PREVIOUS SUPPLIED OR THAT THEY ARE FAULTY / LEAKING.

    Description of Event or Problem · 0

    THE SYRINGES IN THE NEW LOTS HAVE POOR QUALITY OF PRINTING ON THEM, WITH THE NUMBERING FADED IN PLACES. WHILST THE NUMBERS ARE STILL LEGIBLE, THE FADING COULD LEAD OUR CUSTOMERS TO BELIEVE THAT THE SYRINGES ARE OF POORER QUALITY THAN PREVIOUS SUPPLIED OR THAT THEY ARE FAULTY / LEAKING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1291656 SYRINGE 50ML LL TIP 1ML SYRINGE, PISTON FMF BECTON DICKINSON 4143053 30382903096535

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown