BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE 3ML LL 21GA 1-1/2IN MX BUN

    MDR report key: 19420619 · Received May 29, 2024

    Report

    Report Number
    9614033-2024-00046
    Event Type
    Malfunction
    Date Received
    May 29, 2024
    Date of Event
    May 9, 2024
    Report Date
    June 10, 2024
    Manufacturer
    BECTON DICKINSON DE MEXICO
    Product Code
    FMF
    UDI-DI
    00382903086122
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THREE PHOTOS RECEIVED FOR INVESTIGATION. THROUGH VISUAL INSPECTION, THE LACK OF IDENTIFICATION LABEL ON THE COLLECTIVE BOX IS OBSERVED. 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. POSSIBLE ROOT CAUSE IS ASSOCIATED WITH DUE TO PERSONNEL NOT FOLLOWING PROCEDURE. MANUFACTURING PERSONNEL HAVE BEEN NOTIFIED AND ADDITIONAL TRAINING TO REINFORCE HAS BEEN PERFORMED.

    Additional Manufacturer Narrative · 0

    B.3. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD SYRINGE 3ML LL 21GA 1-1/2IN MX BUN LABEL CONTENT WAS MISSING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER TRANSLATED FROM SPANISH TO ENGLISH: "THE PRODUCT 308612 WITH LOT 3034888 IN BOX FOR 100 UNITS ARRIVED WITHOUT LABEL TO END CUSTOMER. WE INFORM YOU THAT THE ORDER FOR THE ADDRESSEE: HOSPITAL DISPATCHED WITH REMITTANCE NO. 311140230962 AND DOCUMENT 192250 FOR: 5 BOXES PRESENTS A NOVELTY IN ITS DELIVERY WITH CAUSE : REPACKING AND CONDITIONING OF MERCHANDISE. RETURN OF 01 BOX X 100 UNITS BECAUSE IT DID NOT ARRIVE WITH THE IDENTIFICATION STICKER."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1940681 BD SYRINGE 3ML LL 21GA 1-1/2IN MX BUN PISTON SYRINGE FMF BECTON DICKINSON DE MEXICO 3334888 00382903086122

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown