BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 10ML LL S/C 200

    MDR report key: 8615956 · Received May 16, 2019

    Report

    Report Number
    1213809-2019-00533
    Event Type
    Malfunction
    Date Received
    May 16, 2019
    Date of Event
    April 29, 2019
    Report Date
    June 21, 2019
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903029953
    PMA / PMN Number
    K980987
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: SINCE NO SAMPLES DISPLAYING THE CONDITION REPORTED ARE AVAILABLE FOR EXAMINATION, WE WERE UNABLE TO FULLY INVESTIGATE THIS INCIDENT. NO ROOT CAUSE CAN BE DETERMINED AS NO SAMPLES WERE RECEIVED. A DEVICE HISTORY RECORD REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION OF THE PROVIDED LOT NUMBER THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. NO CORRECTIVE ACTIONS RECOMMENDED SINCE PRODUCT DEFECT WAS NOT CONFIRMED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF SYRINGE 10ML LL S/C 200 EXPERIENCED VOLUMETRIC INACCURACY. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 302995 BATCH NO.: 8150909 . VERBATIM: AS PER CUSTOMER SYRINGE ARE NOT MEETING THE VOLUME PRECISION NEEDED. A 10 ML GIVE TO THEM 9.7 ML. THIS GIVE THEM A IMPACT ON MED. ADMINISTRATION.

    Additional Manufacturer Narrative · 1

    (B)(6). A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF SYRINGE 10ML LL S/C 200 EXPERIENCED VOLUMETRIC INACCURACY. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 302995, BATCH NO.: 8150909. VERBATIM: AS PER CUSTOMER SYRINGE ARE NOT MEETING THE VOLUME PRECISION NEEDED. A 10 ML GIVE TO THEM 9.7 ML. THIS GIVE THEM A IMPACT ON MED. ADMINISTRATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    407740 SYRINGE 10ML LL S/C 200 PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 8150909 30382903029953

    Patients

    Seq Age Sex Outcome Treatment
    1 Other