BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK¿ SYRINGE

    MDR report key: 17569461 · Received August 17, 2023

    Report

    Report Number
    3003916417-2023-00236
    Event Type
    Malfunction
    Date Received
    August 17, 2023
    Date of Event
    August 7, 2023
    Report Date
    November 2, 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

    PHOTOS RECEIVED BY OUR QUALITY TEAM FOR INVESTIGATION. UPON VISUAL INSPECTION, BOX IS DISPLAYED, ADDITIONALLY TORN PRODUCT PACKAGING BLISTER PACK IS OBSERVED. NO OTHER DEFECTS OR ISSUES OBSERVED. PHYSICAL SAMPLE IS REQUIRED TO FURTHER ANALYZE. 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. 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. H.3. 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

    ADDITIONAL INFORMATION RECEIVED. DURING THE NF (B)(4) CONFERENCE, REFERRING TO THE SUPPLIER, IT WAS OBSERVED THERE IS A DIVERGENCE OF QUANTITY REFERRING TO THE PRODUCT SYRINGE DESC. 05ML LUER LOCK WITHOUT NEEDLE BD, WHICH HAS (B)(4) UNITS OF (B)(4), THE SAME ALSO PRESENTED 2 UNITS WITH TORN PACKAGING AS THE ATTACHED IMAGE. CUSTOMER PROVIDED TO US THE ADDITIONAL INFORMATION BELOW. COULD YOU PROVIDE THE SHIPPING BOX NUMBER OR SEND PHOTOS WHERE YOU CAN SEE THE BOX LABEL? PLEASE SEE ATTACHED. WHICH REGION OF THE PACKAGE IS TORN, NEAR THE PEAK, NEAR, OR ON THE SIDES? BOTH WERE CLOSE TO THE SIDE. IMAGES ATTACHED FOR BETTER UNDERSTANDING. DID YOU NOTICE ANY DAMAGE ALSO ON THE SHIPPING BOX WHERE THE PRODUCTS WERE RECEIVED? NO DAMAGE WAS FOUND ON THE BOXES RECEIVED. ON THE FORM IT IS QUOTED "AS PER THE ATTACHED IMAGE", COULD YOU SEND US THE PHOTOS THAT SHOW THE DEVIATIONS? PLEASE, SEE ATTACHED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 2 BD PLASTIPAK¿ SYRINGES HAD TORN PACKAGING UNITS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM PORTUGUESE: "DURING THE NF 961927 CONFERENCE, REFERRING TO THE SUPPLIER, IT WAS OBSERVED THERE IS A DIVERGENCE OF QUANTITY REFERRING TO THE PRODUCT SYRINGE DESC. 05ML LUER LOCK WITHOUT NEEDLE BD, WHICH HAS 680 UNITS OF 700, THE SAME ALSO PRESENTED + 2 UNITS WITH TORN PACKAGING".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2050360 BD PLASTIPAK¿ SYRINGE PISTON SYRINGE FMF BECTON DICKINSON IND. CIRURGICAS LTDA 3108614

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown