BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE PLASTIPAK 5ML S/SU

    MDR report key: 21554314 · Received March 7, 2025

    Report

    Report Number
    3003916417-2025-00022
    Event Type
    Malfunction
    Date Received
    March 7, 2025
    Date of Event
    February 10, 2025
    Report Date
    April 4, 2025
    Manufacturer
    BECTON DICKINSON IND. CIRURGICAS LTDA
    Product Code
    FMF
    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

    (B)(6) FOLLOW UP IT WAS REPORTED THE SYRINGES HAD PART OF THE BODY BROKEN. TO AID IN THE INVESTIGATION, TWO PHOTOS WERE RECEIVED FOR EVALUATION BY OUR QUALITY TEAM. IN THE PHOTOS, IT IS POSSIBLE TO CONFIRM THE PLUNGER RODS ARE BROKEN. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 990175, LOT 4234795. INSPECTIONS WERE CARRIED OUT ACCORDING TO PLAN AND NO RECORD OF THIS DEFECT WAS OBSERVED. THERE WERE NO QUALITY OCCURRENCES. MAINTENANCE RECORDS WERE REVIEWED, AND TWO RECORDS WERE FOUND THAT MAY BE RELATED TO THE REPORTED EVENT. ACCORDING TO THE RECORDS, THERE WAS A BREAK IN THE ROD AT THE DISC INLET AND A BREAK IN THE ROD DURING ASSEMBLY DUE TO MISALIGNMENT AND JAMMING. CORRECTIONS MADE DURING PROCESSES INCLUDED REPLACING THE DAMAGED FISHERMAN AND ADJUSTMENTS TO BLOWER NOZZLES. AN OPERATIONAL NOTIFICATION WILL BE ISSUED. BASED ON THE INVESTIGATION, BD CONFIRMS THE EVENT REPORTED.

    Additional Manufacturer Narrative · 0

    IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    HAS THERE BEEN ANY HARM TO PATIENTS, HEALTHCARE PROFESSIONALS? NO ARE THERE ANY PATIENTS INVOLVED, PLEASE CONFIRM? NO PATIENT WAS NOT USED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD SYRINGE PLASTIPAK 5ML S/SU PLUNGER ROD WAS BROKEN / DAMAGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER TRANSLATED FROM SPANISH TO ENGLISH: THE CENTRAL MIXING SERVICE REPORTS: 10 UNITS OF 5ML SYRINGES HAVE BROKEN DOWN; PART OF THEIR BODY IS BROKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1281656 BD SYRINGE PLASTIPAK 5ML S/SU PISTON SYRINGE FMF BECTON DICKINSON IND. CIRURGICAS LTDA 4234795

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown