BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE PLASTIPAK 20ML LL S/SU

    MDR report key: 23117848 · Received September 22, 2025

    Report

    Report Number
    3003916417-2025-00190
    Event Type
    Malfunction
    Date Received
    September 22, 2025
    Date of Event
    September 8, 2025
    Report Date
    October 30, 2025
    Manufacturer
    BECTON DICKINSON IND. CIRURGICAS LTDA
    Product Code
    FMF
    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

    ADDITIONAL INFORMATION: (H) ANNEX A CODING UPDATED TO BEST CAPTURE THE REPORTED EVENT. INVESTIGATION RESULTS: IT WAS PERFORMED THE DHR, MAINTENANCE RECORDS AND QUALITY NOTIFICATIONS, AND NO DEVIATIONS ASSOCIATED WITH THE BATCHES IN QUESTION WERE FOUND. UNFORTUNATELY, AS NO SAMPLES OR PHOTOS WERE PROVIDED BY THE CUSTOMER, WE ARE UNABLE TO CONDUCT A DETAILED INVESTIGATION OR DETERMINE THE ROOT CAUSE OF THE REPORTED INCIDENT. BASED ON THE INFORMATION AVAILABLE, WE CANNOT CONFIRM THE VALIDITY OF THE QUERY. OUR MANUFACTURING PROCESS IS VALIDATED AGAINST SPECIFIC RESOURCE CRITERIA, AND THE INCIDENT IDENTIFIED IN THIS CONSULTATION WILL BE MONITORED TO ASSESS TRENDS. AS THIS OCCURRENCE DOES NOT EXCEED THE BATCH'S ACCEPTABLE QUALITY LIMIT (AQL), NO ADDITIONAL CORRECTIVE OR PREVENTIVE ACTION IS PROPOSED AT THIS TIME.

    Additional Manufacturer Narrative · 0

    THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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 PLASTIPAK 20ML LL S/SU BARREL WAS CRACKED. THE FOLLOWING INFORMATION WAS REPORTED BY THE INITIAL REPORTER: OBSERVED DURING ADMINISTRATION, CRACK, CAUSING LEAKAGE OF THE DARATUMUMAB MEDICATION. ITEM: 990687 - 20ML SYRINGE WITHOUT LUER LOCK NEEDLE (BD) (250) LOT: 3349258 QUANTITY: (B)(4) UNIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    228244 BD SYRINGE PLASTIPAK 20ML LL S/SU PISTON SYRINGE FMF BECTON DICKINSON IND. CIRURGICAS LTDA 3349258

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown