BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 20ML LL S/C 50

    MDR report key: 11822296 · Received May 13, 2021

    Report

    Report Number
    9614033-2021-00056
    Event Type
    Malfunction
    Date Received
    May 13, 2021
    Date of Event
    April 14, 2021
    Report Date
    May 21, 2021
    Manufacturer
    BECTON DICKINSON DE MEXICO
    Product Code
    FMF
    PMA / PMN Number
    K151766
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: SINCE NO SAMPLES DISPLAYING THE CONDITION REPORTED ARE AVAILABLE FOR EXAMINATION, WE WERE UNABLE TO FULLY INVESTIGATE THIS INCIDENT, THEREFORE A ROOT CAUSE COULD NOT BE DETERMINED. 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. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SYRINGE 20ML LL S/C 50 PACKAGING RIPPED AND CONTAMINATED THE STERILE FIELD. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 303310 BATCH NO.: 0015659, 0098739, 0161042. IT WAS REPORTED THAT PACKAGING SPLITS AND RIPS WHEN OPENING, CONTAMINATING THE STERILE FIELD.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 0015659, MEDICAL DEVICE EXPIRATION DATE: 2025-01-31, DEVICE MANUFACTURE DATE: (B)(6) 2020. MEDICAL DEVICE LOT #: 0098739, MEDICAL DEVICE EXPIRATION DATE: 2025-04-30, DEVICE MANUFACTURE DATE: (B)(6) 2020. MEDICAL DEVICE LOT #: 0290115, MEDICAL DEVICE EXPIRATION DATE: 2025-10-31, DEVICE MANUFACTURE DATE: (B)(6) 2020. THE CUSTOMER'S ADDRESS IS UNKNOWN. NEW JERSEY (NJ), USA HAS BEEN USED AS A DEFAULT. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SYRINGE 20ML LL S/C 50 PACKAGING RIPPED AND CONTAMINATED THE STERILE FIELD. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 303310, BATCH NO.: 0015659, 0098739, 0161042. IT WAS REPORTED THAT PACKAGING SPLITS AND RIPS WHEN OPENING, CONTAMINATING THE STERILE FIELD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    712372 SYRINGE 20ML LL S/C 50 PISTON SYRINGE FMF BECTON DICKINSON DE MEXICO SEE H.10

    Patients

    Seq Age Sex Outcome Treatment
    1