BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 50ML LL TIP 1ML

    MDR report key: 19686663 · Received July 7, 2024

    Report

    Report Number
    1911916-2024-00465
    Event Type
    Malfunction
    Date Received
    July 7, 2024
    Date of Event
    June 19, 2024
    Report Date
    July 11, 2024
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMF
    UDI-DI
    30382903096535
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PR 10383406 FOLLOW UP . IT WAS REPORTED THE SYRINGE MARKINGS ARE PARTIALLY MISSING. TO AID IN THE INVESTIGATION, ONE PHOTO WAS PROVIDED FOR EVALUATION BY OUR QUALITY TEAM. THE PHOTO SHOWS A SYRINGE WITH NO PACKAGING BLISTER AND PART OF THE SCALE MARKING MISSING. NO OTHER DEFECTS OR IMPERFECTIONS WERE OBSERVED. THIS DEFECT COULD OCCUR IF THERE WAS A JAM DURING THE SYRINGE BARREL PRINTING PROCESS. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 309653, LOT 4058940. 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.

    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. THE ACTUAL DATE OF EVENT IS UNKNOWN. THE DATE RECEIVED BY MANUFACTURER WAS ENTERED INTO THE DATE OF EVENT FIELD.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION RECEIVED. MATERIAL # 309653. BATCH # 4058940. IT WAS REPORTED BY CUSTOMER THAT SYRINGE MARKINGS ARE PARTIALLY MISSING. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. PRODUCT NAME SYR 50ML. MANUFACTURER BD. CATALOG # 309653. LOT / SERIAL # (B)(6). ITEM # 162287. ISSUE DESCRIPTION SYRINGE MARKINGS ARE PARTIALLY MISSING, SEE IMAGE ATTACHED.

    Description of Event or Problem · 0

    MATERIAL # 309653 BATCH # 4058940 IT WAS REPORTED BY CUSTOMER THAT SYRINGE MARKINGS ARE PARTIALLY MISSING. RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. PRODUCT NAME SYR 50ML MANUFACTURER BD. CATALOG # 309653. LOT / SERIAL # (B)(6). ITEM # 162287. ISSUE DESCRIPTION SYRINGE MARKINGS ARE PARTIALLY MISSING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    894555 SYRINGE 50ML LL TIP 1ML SYRINGE, PISTON FMF BECTON DICKINSON 4058940 30382903096535

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown