BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 3ML LL 200 S/C

    MDR report key: 11220023 · Received January 23, 2021

    Report

    Report Number
    2243072-2021-00151
    Event Type
    Malfunction
    Date Received
    January 23, 2021
    Date of Event
    December 24, 2020
    Report Date
    January 19, 2021
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMF
    UDI-DI
    00382903096572
    PMA / PMN Number
    SEE H.10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    UNKNOWN MANUFACTURER: (B)(4). MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. PMA/510(K)#: K980987 OR K151766. A LOT NUMBER COULD NOT BE CONFIRMED FOR THIS INCIDENT AND WITHOUT THIS INFORMATION WE ARE UNABLE TO DETERMINE THE 510K. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SYRINGE 3ML LL 200 S/C HAD FOREIGN MATTER IN THE SYRINGE. THIS OCCURRED ON 5 OCCASIONS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 309657 BATCH NO: UNKNOWN (PROVIDED M722098). IT WAS REPORTED THAT THE CALLER DISCOVERED A WHITE FILAMENT IN THE SYRINGE. EVENT DESCRIPTION PER EMAIL STATES: CALLER REPORTED A WHITE FILAMENT IN THE SYRINGE AND WAS TOLD TO CALL BACK IF IT HAPPENS AGAIN. NUMBER OF OCCURRENCES: 5. DID THE CALLER INSERT THE NEEDLE INTO THE CARTRIDGE AND ENCOUNTER FILL RESISTANCE? NO. DID ISSUE CAUSE ANY INJURY? NO. DID CUSTOMER REQUIRE MEDICAL INTERVENTION? NO, CUSTOMER RECEIVED NORMAL ASSISTANCE BY A 3RD PARTY BUT WAS NOT INCAPACITATED DUE TO ISSUE. IS PRODUCT AVAILABLE FOR RETURN TO BD? YES. CTS INFORMED CALLER BD MIGHT FOLLOW UP REGARDING RETURN OF SYRINGE/NEEDLE. CALLER ACKNOWLEDGED.(CONTACT: +). RESOLUTION: CALLER SUCCESSFULLY FILLED A CARTRIDGE WITH INSULIN. NO FURTHER FOLLOW UP IS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    116550 SYRINGE 3ML LL 200 S/C PISTON SYRINGE FMF BECTON DICKINSON UNKNOWN 00382903096572

    Patients

    Seq Age Sex Outcome Treatment
    1 7 YR