BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE PLASTIPAK 3ML S/SU

    MDR report key: 24611613 · Received March 16, 2026

    Report

    Report Number
    3003916417-2026-00044
    Event Type
    Malfunction
    Date Received
    March 16, 2026
    Date of Event
    November 25, 2025
    Report Date
    March 16, 2026
    Manufacturer
    BECTON DICKINSON IND. CIRURGICAS LTDA
    Product Code
    FMI
    PMA / PMN Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    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 FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD EVA-AI3-SM3 SYRINGE PLASTIPAK 3ML S/SU PACKAGE WAS DAMAGED. 3 ML SYRINGE, LOT: 5120252 - (B)(4) UNITS, 1 FOREIGN BODY IN THE PACKAGE, 1 OPENING AT THE BEGINNING OF THE PACKAGE. ADDITIONAL INFORMATION RECEIVED ON 23FEB2026. CAN YOU SHARE THE DATE OF OCCURRENCE OF THE EVENT IN DD/MM/YYYY? 25/11/2025. CAN YOU SHARE THE SAMPLE PHOTO(S)/VIDEO(S)? YES. WAS THE INCIDENT NOTIFIED TO ANVISA? IF YES, WHAT IS THE NOTIFICATION NUMBER? WE DID NOT NOTIFY ANVISA. FOR SAMPLE COLLECTION AND REPLACEMENT, PLEASE PROVIDE THE FOLLOWING INFORMATION: ENTITY NAME: ESSENCIAL MANIPULAÇÕES ESPECIAIS LTDA. CNPJ NUMBER: 20.511.326/0001-90. ICMS TAXPAYER (YES/NO): YES. IF YOU ARE AN ICMS TAXPAYER, ISSUANCE OF INVOICE: YES. PRODUCT PURCHASE INVOICE NUMBER: CIR MAFRA NF: (B)(4). FULL ADDRESS: (B)(6). SECTOR/DEPARTMENT: WAREHOUSE. HOW MANY UNITS ARE AVAILABLE FOR COLLECTION: (B)(4) ITEMS. CONTAMINATED SAMPLE ¿ IF YES, SPECIFY THE SUBSTANCE: NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    254989 BD SYRINGE PLASTIPAK 3ML S/SU NEEDLE, HYPODERMIC, SINGLE LUMEN FMI BECTON DICKINSON IND. CIRURGICAS LTDA 5120252

    Patients

    Seq Age Sex Outcome Treatment
    1