BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE PLASTIPAK 20ML LL S/SU

    MDR report key: 21403120 · Received February 18, 2025

    Report

    Report Number
    3003916417-2025-00015
    Event Type
    Malfunction
    Date Received
    February 18, 2025
    Date of Event
    January 29, 2025
    Report Date
    March 1, 2025
    Manufacturer
    BECTON DICKINSON IND. CIRURGICAS LTDA
    Product Code
    FMF
    UDI-DI
    07891463003782
    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 FILED.

    Additional Manufacturer Narrative · 0

    (B)(4) FOLLOW UP FOR DEVICE EVALUATION. IT WAS REPORTED THE BLACK RUBBER OF THE SYRINGE IS DAMAGED AND UNUSABLE. TO AID IN THE INVESTIGATION, THREE PHOTOS WERE RECEIVED FOR EVALUATION BY OUR QUALITY TEAM. THE PROVIDED PHOTOS SHOW THE FAILURE OF THE STOPPER POSITIONING. THIS OCCURS DURING THE ASSEMBLY PROCESS WHEN THERE IS A MISALIGNMENT OF COMPONENTS. THIS TYPE OF CONDITION ONLY AFFECTS THE COMPONENT¿S APPEARANCE, AS THE EQUIPMENT AUTOMATICALLY REJECTS PIECES THAT DO NOT MEET THE TIGHTNESS LIMITS, REDUCING HARM TO THIRD PARTIES IN CASE OF USE. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 990687, LOT 4207886. INSPECTIONS WERE CARRIED OUT ACCORDING TO PLAN AND NO RECORD OF THIS DEFECT WAS OBSERVED. THERE WERE NO QUALITY OCCURRENCES OR MAINTENANCE EVENTS RELATED TO THIS INCIDENT. CURRENT CONTROLS INCLUDE VISUAL INSPECTIONS EVERY HOUR DURING THE MATERIAL CYCLE IN THE PACKAGING PROCESS. TO DATE, THERE HAVE BEEN NO OTHER SIMILAR EVENTS REPORTED FOR THIS LOT. BASED ON THE INVESTIGATION, BD CONFIRMS THE COMPLAINT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD SYRINGE PLASTIPAK 20ML LL S/SU STOPPER WAS DEFECTIVE / DEFORMED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER TRANSLATED FROM PORTUGUESE TO ENGLISH: THE BLACK RUBBER OF THE SYRINGE IS DAMAGED AND UNUSABLE. ADDITIONAL INFORMATION PROVIDED: IS THERE ANY PATIENT IMPACT, IF YES, PLEASE EXPLAIN IN DETAIL? A: NO. CAN YOU PLEASE CONFIRM THE DATE OF EVENT? A: 29/01. CAN YOU PLEASE CONFIRM THE AFFECTED QUANTITY? A: ONE UNIT. WAS ANVISA NOTIFIED? IF YES, WHAT WAS THE NOTIFICATION NUMBER? A: YES, 2025 01 004309. FOR SAMPLE COLLECTION AND REPLACEMENT, PLEASE INFORM. NAME OF ORGANIZATION - (B)(6). CNPJ NUMBER - (B)(4). ICMS TAXPAYER (YES/NO) - NO. PRODUCT PURCHASE INVOICE NUMBER - I DON'T HAVE ONE. SECTOR/DEPARTMENT - DISPENSING PHARMACY. HOW MANY UNITS ARE AVAILABLE FOR COLLECTION - ONE UNIT. IS THE SAMPLE CONTAMINATED, IF SO, THE SUBSTANCE - NO. FULL ADDRESS (STREET, ZIP CODE, NEIGHBORHOOD, CITY AND STATE): (B)(6). CONTACT NAME/TELEPHONE: CONTACT VIA E-MAIL.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2641981 BD SYRINGE PLASTIPAK 20ML LL S/SU PISTON SYRINGE FMF BECTON DICKINSON IND. CIRURGICAS LTDA 4207886 07891463003782

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown