BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 3ML LL W/NDL 25X5/8 RB

    MDR report key: 9497921 · Received December 19, 2019

    Report

    Report Number
    1213809-2019-01285
    Event Type
    Malfunction
    Date Received
    December 19, 2019
    Date of Event
    December 4, 2019
    Report Date
    February 4, 2020
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903095705
    PMA / PMN Number
    K980987
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: ONE 100-COUNT BOX FROM BATCH 9140825 (P/N 309570) CONTAINING ONE HUNDRED 3ML SYRINGE WITH NEEDLES IN BLISTER PACKS FROM BATCH 9071827 (P/N 309582) WERE RECEIVED AND EVALUATED. IT WAS OBSERVED THE BOX WAS RECEIVED OPEN AND APPEARED TO HAVE BEEN RESEALED. IT WAS ALSO OBSERVED THE PRODUCT INSIDE THE BOX DID NOT MATCH THE LABEL ON THE BOX AND WAS REJECTABLE PER PRODUCT SPECIFICATION. POTENTIAL ROOT CAUSE COULD NOT BE DETERMINED. AT THIS TIME, NO CORRECTIVE ACTIONS ARE NECESSARY. FURTHERMORE, 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. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. H3 OTHER TEXT : SEE SECTION H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF SYRINGE 3ML LL W/NDL 25X5/8 RB EXPERIENCED INCORRECT LABEL INFORMATION WHICH WAS NOTED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 309570, BATCH NO.: 9140825. VERBATIM: 1 1/2 NEEDLES IN 5/8 BOX.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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 3ML LL W/NDL 25X5/8 RB EXPERIENCED INCORRECT LABEL INFORMATION WHICH WAS NOTED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 309570 BATCH NO.: 9140825. VERBATIM: 1 1/2 NEEDLES IN 5/8 BOX.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1294867 SYRINGE 3ML LL W/NDL 25X5/8 RB PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 309570 9140825 30382903095705

    Patients

    Seq Age Sex Outcome Treatment
    1 Other