BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK¿ SYRINGES

    MDR report key: 17484264 · Received August 8, 2023

    Report

    Report Number
    3003916417-2023-00209
    Event Type
    Malfunction
    Date Received
    August 8, 2023
    Date of Event
    July 25, 2023
    Report Date
    November 1, 2023
    Manufacturer
    BECTON DICKINSON IND. CIRURGICAS LTDA
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    TWO PHOTOS RECEIVED BY OUR QUALITY TEAM FOR INVESTIGATION. THROUGH VISUAL INSPECTION, PRODUCT PACKAGING IS OBSERVED WITH MATERIAL 990687, ADDITIONALLY A SYRINGE IS OBSERVED, NO DEFECTS OR ISSUES OBSERVED. PHYSICAL SAMPLE IS REQUIRED TO FURTHER ANALYZE. THE LOT NUMBER IS UNKNOWN, THEREFORE DEVICE HISTORY RECORD REVIEW (DHR) OR QUALITY NOTIFICATION REVIEW (QN) COULD NOT BE PERFORMED. NO CHANGES IN MANUFACTURING PROCESS OR RAW MATERIALS FOR THIS REFERENCE HAVE BEEN PERFORMED THAT COULD MODIFY THE BEHAVIOR OF THE CASES OR PRODUCT AND COULD BE RELATED TO THIS DEFECT. BASED ON THE QUALITY TEAM'S INVESTIGATION, WE ARE NOT ABLE TO IDENTIFY A ROOT CAUSE RELATED TO OUR MANUFACTURING PROCESS AT THIS TIME.

    Additional Manufacturer Narrative · 0

    B.3. DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. D.4. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. H.4. DEVICE MANUFACTURE DATE: UNKNOWN. 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

    THE REPORT OF THE 20ML SYRINGE, WHICH HAS OPACITY THROUGHOUT THE SYRINGE AND WE ARE TOLD THAT THE HOSPITAL IS UNABLE TO DETECT IF ANY SOLUTION IS CLOUDY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD PLASTIPAK¿ SYRINGES HAS OPACITY THROUGHOUT THE SYRINGE AND UNABLE TO DETECT IF ANY SOLUTION IS CLOUDY. THE FOLLOWING WAS RECEIVED BY THE INITIAL REPORTER: THE REPORT OF THE 20ML SYRINGE, WHICH HAS OPACITY THROUGHOUT THE SYRINGE AND WE ARE TOLD THAT THE HOSPITAL IS UNABLE TO DETECT IF ANY SOLUTION IS CLOUDY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    318054 BD PLASTIPAK¿ SYRINGES PISTON SYRINGE FMF BECTON DICKINSON IND. CIRURGICAS LTDA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown