BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 10ML LL

    MDR report key: 11382312 · Received February 25, 2021

    Report

    Report Number
    2243072-2021-00609
    Event Type
    Malfunction
    Date Received
    February 25, 2021
    Date of Event
    February 1, 2021
    Report Date
    April 13, 2021
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMF
    UDI-DI
    00382903096046
    PMA / PMN Number
    SEE H.10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH ADDITIONAL INFORMATION: MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE POTENTIAL LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: D.4. MEDICAL DEVICE LOT #: UNKNOWN D.4. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN H.4. DEVICE MANUFACTURE DATE: UNKNOWN D.4. MEDICAL DEVICE LOT #: 0062321 D.4. MEDICAL DEVICE EXPIRATION DATE: 2025-02-28 H.4. DEVICE MANUFACTURE DATE: 2020-04-08 D.4. MEDICAL DEVICE LOT #: 0098680 D.4. MEDICAL DEVICE EXPIRATION DATE: 2025-04-30 H.4. DEVICE MANUFACTURE DATE: 2020-06-12 D.4. MEDICAL DEVICE LOT #: 0044859 D.4. MEDICAL DEVICE EXPIRATION DATE: 2025-02-28 H.4. DEVICE MANUFACTURE DATE: 2020-04-08 D.4. MEDICAL DEVICE LOT #: 9339588 D.4. MEDICAL DEVICE EXPIRATION DATE: 2024-12-31 H.4. DEVICE MANUFACTURE DATE: 2020-01-29.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES, D10: RETURNED TO MANUFACTURER ON: 2021-04-14. H6: INVESTIGATION SUMMARY SAMPLES AND PHOTO RECEIVED FOR INVESTIGATION. ONE LOOSE 10ML SYRINGE IN A BIOHAZARD BAG WAS RECEIVED. THE SAMPLE WAS VISUALLY EVALUATED. THE SYRINGE WAS OBSERVED TO HAVE ONE BROKEN PLUNGER ROD RIB. THE BARREL WAS IDENTIFIED TO BE FROM MOLD M-77, WHILE PLUNGER ROD FROM M-79. THE LOT NUMBER IS UNKNOWN, THEREFORE DEVICE HISTORY RECORD REVIEW (DHR) OR QUALITY NOTIFICATION REVIEW (QN) COULD NOT BE PERFORMED. WITHOUT A LOT NUMBER, THE ROOT CAUSE COULD NOT BE DETERMINED. AT THIS TIME, NO CORRECTIVE ACTIONS ARE NECESSARY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SYRINGE 10ML LL WAS DAMAGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CUSTOMER REPORTED ABOUT A DAMAGED BARREL AND A DAMAGED PLUNGER ROD.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SYRINGE 10ML LL WAS DAMAGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CUSTOMER REPORTED ABOUT A DAMAGED BARREL AND A DAMAGED PLUNGER ROD.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. UNKNOWN MANUFACTURER: THERE ARE MULTIPLE BD LOCATIONS WHERE THIS UNSPECIFIED BD DEVICE MAY HAVE BEEN MANUFACTURED. A LOT NUMBER COULD NOT BE CONFIRMED FOR THIS INCIDENT AND WITHOUT THIS INFORMATION WE ARE UNABLE TO DETERMINE WHERE THE DEVICE WAS MANUFACTURED. THEREFORE, BD CORPORATE HEADQUARTERS IN (B)(4) HAS BEEN LISTED AND THE (B)(4) REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER. 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 CORRECT 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 10ML LL WAS DAMAGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CUSTOMER REPORTED ABOUT A DAMAGED BARREL AND A DAMAGED PLUNGER ROD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    279003 SYRINGE 10ML LL SYRINGE FMF BECTON DICKINSON SEE H.10 00382903096046

    Patients

    Seq Age Sex Outcome Treatment
    1