BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE PLASTIPAK 10ML S/SU

    MDR report key: 19594133 · Received June 24, 2024

    Report

    Report Number
    3003916417-2024-00159
    Event Type
    Malfunction
    Date Received
    June 24, 2024
    Date of Event
    May 31, 2024
    Report Date
    August 23, 2024
    Manufacturer
    BECTON DICKINSON IND. CIRURGICAS LTDA
    Product Code
    FMF
    UDI-DI
    07891463000378
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    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.

    Additional Manufacturer Narrative · 0

    PHOTOS RECEIVED BY OUR QUALITY TEAM FOR INVESTIGATION. THROUGH VISUAL INSPECTION, IT WAS OBSERVED THAT THE STOPPER WAS INCORRECTLY ASSEMBLED TO THE PLUNGER, DISTORTED AGAINST THE BARREL WALL. 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. THIS ISSUE WAS DETERMINED TO HAVE OCCURRED AS A RESULT OF IMPROPER ALIGNMENT OF THE PLUNGER/STOPPER TO THE BARREL DURING ASSEMBLY. FINAL PRODUCTS IN THIS MANUFACTURING LINE, FOR THIS REFERENCE ARE SAMPLED AND THEY ARE SUBJECTED TO VISUAL AND FUNCTIONAL INSPECTIONS DURING THE DIFFERENT MANUFACTURING SUB-PROCESSES ACCORDING TO PROCEDURES.

    Additional Manufacturer Narrative · 0

    (B)(4) FOLLOW UP REPORT FOR CORRECTION. THE DATE OF EVENT WAS INCORRECT IN THE INITIAL MDR, DATE SHOULD BE 31/05/2024. THE EVENT OR PROBLEM WAS INCORRECT IN THE INITIAL MDR. EVENT OR PROBLEM SHOULD INCLUDE RUBBER "PLUNGER" AND NOT RUBBER "NOZZLE", AS EMBOLO MEANS PLUNGER IN PORTUGUESE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD SYRINGE PLASTIPAK 10ML S/SU STOPPER WAS DEFECTIVE/DAMAGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER TRANSLATED FROM PORTUGUESE TO ENGLISH: "IDENTIFIED A 10 ML DISPOSABLE SYRINGE WITH A THREADED NOZZLE SHOWING DEFORMITY IN THE RUBBER NOZZLE. LOT. 4054830 VAL. 02/2029"

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    IDENTIFIED A 10 ML DISPOSABLE SYRINGE WITH A THREADED NOZZLE SHOWING DEFORMITY IN THE RUBBER PLUNGER. LOT. 4054830 VAL. 02/2029.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2182056 BD SYRINGE PLASTIPAK 10ML S/SU PISTON SYRINGE FMF BECTON DICKINSON IND. CIRURGICAS LTDA 4054830 07891463000378

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown