BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE PLASTIPAK 5ML S/SU

    MDR report key: 21146081 · Received January 13, 2025

    Report

    Report Number
    3003916417-2025-00002
    Event Type
    Malfunction
    Date Received
    January 13, 2025
    Date of Event
    December 23, 2024
    Report Date
    February 17, 2025
    Manufacturer
    BECTON DICKINSON IND. CIRURGICAS LTDA
    Product Code
    FMF
    UDI-DI
    07891463001771
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILE.

    Additional Manufacturer Narrative · 0

    (B)(4) FOLLOW UP FOR DEVICE EVALUATION: IT WAS REPORTED THE SYRINGE IS BROKEN. TO AID IN THE INVESTIGATION, A SAMPLE AND PHOTO WERE RECEIVED FOR EVALUATION BY OUR QUALITY TEAM AND THE BARREL CRACKED DEFECT WAS CONFIRMED. IT IS POSSIBLE TO SEE THERE WAS A JAM IN THE CYLINDER NOZZLE OF THE PHYSICAL SAMPLE THAT INDUCED THE BREAKAGE. THIS DEFECT COULD OCCUR IF THERE WERE MISALIGNED DISCS, OR A PIECE JAMMED INTO A DISC DURING THE MANUFACTURING PROCESS. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 990175, LOT 4207843. THERE WERE NO QUALITY OCCURRENCES OR MAINTENANCE EVENTS RELATED TO THIS INCIDENT. AUTOMATIC LEAK TESTS AND VISUAL INSPECTIONS ARE PERFORMED EVERY TWO HOURS DURING THE ASSEMBLY PROCESS AND THE DEFECT WAS NOT IDENTIFIED DURING THE SAMPLE INSPECTIONS PERFORMED. ALL PRODUCTION PROCESSES ARE VALIDATED ACCORDING TO STRICT ACCEPTANCE CRITERIA. BASED ON THE INVESTIGATION WITH THE RETURNED SAMPLE ANALYSIS BD WAS ABLE TO CONFIRM THE DEFECT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD SYRINGE PLASTIPAK 5ML S/SU BARREL CRACKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER TRANSLATED FROM PORTUGUESE TO ENGLISH: REASON: 5 ML SYRINGE BROKEN AT THE TOP. ADDITIONAL INFORMATION RECEIVED. DECEMBER 28, 2024. WAS THERE ANY IMPACT ON THE HEALTH OF PATIENTS? DETAIL. NO. COULD YOU INFORM THE DATE OF OCCURRENCE OF THE EVENT? 2023/12. WAS THERE NOTIFICATION TO ANVISA? IF SO, WHAT IS THE NOTIFICATION NUMBER? TO CONFIRM: YES, (B)(4).

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1988460 BD SYRINGE PLASTIPAK 5ML S/SU PISTON SYRINGE FMF BECTON DICKINSON IND. CIRURGICAS LTDA 4207843 07891463001771

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown