BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK¿ SYRINGES

    MDR report key: 17687077 · Received September 5, 2023

    Report

    Report Number
    3003916417-2023-00263
    Event Type
    Malfunction
    Date Received
    September 5, 2023
    Date of Event
    August 17, 2023
    Report Date
    October 1, 2023
    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

    SINCE NO SAMPLES DISPLAYING THE CONDITION REPORTED ARE AVAILABLE FOR EXAMINATION, WE WERE UNABLE TO FULLY INVESTIGATE THIS INCIDENT, THEREFORE A ROOT CAUSE COULD NOT BE DETERMINED. FURTHERMORE, A DEVICE HISTORY RECORD REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION OF THE PROVIDED LOT NUMBER THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. WE WOULD BE VERY INTERESTED IN EXAMINING PRODUCT THAT DOES NOT MEET YOUR EXPECTATIONS AND OUR QUALITY STANDARDS. SHOULD YOU AGAIN EXPERIENCE ANY PROBLEMS WITH OUR PRODUCT WE WOULD APPRECIATE THE OPPORTUNITY TO CONDUCT A THOROUGH ANALYSIS. EXAMINATION OF THE PRODUCT INVOLVED MAY PROVIDE CLARIFICATION AS TO THE CAUSE FOR THE REPORTED FAILURE.

    Additional Manufacturer Narrative · 0

    H3. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    NO ADDITIONAL INFO RECEIVED. WE WILL RETURN 800 10 ML SYRINGES, AS THEY ARE CAUSING A LOT OF PROBLEMS AT THE TIME OF COLLECTION, THERE ARE SEVERAL COMPLAINTS FROM COLLECTORS, AMONG THEM: LACK OF VACUUM IN THE SYRINGE, THE PLUNGER DOES NOT WORK PROPERLY AND IT IS ALL DISTORTED INSIDE THE SYRINGE, AND ENDS UP GENERATING RECOLLECTION TO THE PATIENT. AGAIN WE HAVE THIS PROBLEM. FOLLOW THE BATCH NUMBER: 3170743 FAB 2023-07.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD PLASTIPAK¿ SYRINGES STOPPER IS DEFECTIVE. THE FOLLOWING WAS TRANSLATED FROM PORTUGUESE TO ENGLISH: THERE ARE SEVERAL COMPLAINTS FROM COLLECTORS, AMONG THEM: LACK OF VACUUM IN THE SYRINGE, THE PLUNGER DOES NOT WORK PROPERLY AND IT IS ALL DISTORTED INSIDE THE SYRINGE, AND ENDS UP GENERATING RECOLLECTION TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1455235 BD PLASTIPAK¿ SYRINGES PISTON SYRINGE FMF BECTON DICKINSON IND. CIRURGICAS LTDA 3170743

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown