BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE PLASTIPAK 3ML S/SU

    MDR report key: 10412934 · Received August 17, 2020

    Report

    Report Number
    3003916417-2020-00240
    Event Type
    Malfunction
    Date Received
    August 17, 2020
    Date of Event
    July 22, 2020
    Report Date
    August 31, 2020
    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
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY IT WAS PERFORMED THE DHR, MAINTENANCE RECORD ANALYSIS AND QUALITY NOTIFICATION ANALYSIS AND NO DEVIATION WERE FOUND FOR THESE BATCH. PHOTOS WERE SENT BY THE CUSTOMER FOR EVALUATION. IT WAS REPORTED TO THE INCIDENT ¿MISSING 01 BOX OF LOT 0133737 AND LEFTOVER OF 01 BOX OF SYRINGE DESC.03ML S / AG C / 1000 LL-BD OF LOT 0133655.¿ AS VERIFIED BY BD CURITIBA LOGISTICS DEP THESE MATERIALS ARE PALLETIZED BEFORE THE STERILIZATION PROCESS AND DOES NOT UNDERGO PALLETIZING AFTER THIS PROCESS. AS REPORTED BY THE BD DISTRIBUTION CENTER, THE MATERIAL HAS NOT BEEN REPACKAGED IN DC. IT WAS ALSO EVALUATED THE MANUFACTURING PERIOD OF THE MENTIONED MATERIALS AND THE PRODUCTION DATES ARE CLOSE: LOTE 03ML PLASTIPAK: 0133655 FABRICAÇÃO: 18/6/20 A 21/6/20 LOTE 10ML PLASTIPAK: 0133737 FABRICAÇÃO: 18/6/20 A 20/6/20 THUS, FROM THE INFORMATION EVALUATED BY LOGISTICS BD CURITIBA AND INFORMATION RECEIVED FROM THE CUSTOMER IS POSSIBLE TO CONFIRM THE COMPLAINT. AFTER THESE ASSESSMENTS, THE POSSIBLE CAUSE FOR THE INCIDENT WAS A MIXTURE DURING THE MANUAL PALLETIZING PROCESS PERFORMED PRIOR TO STERILIZATION OF MATERIALS BY OPERATIONAL ERROR. THE INCIDENT IDENTIFIED FROM THIS COMPLAINT WILL BE MONITORED FOR TREND ASSESSMENT. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SYRINGE PLASTIPAK 3ML S/SU CONTAINED A MIX OF PRODUCTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "MISSING 01 BOX OF LOT 0133737 AND LEFTOVER OF 01 BOX OF SYRINGE DESC.03ML S / AG C / 1000 LL-BD OF LOT 0133655."

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.(B)(4).INITIAL REPORTER PHONE NUMBER: (B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SYRINGE PLASTIPAK 3ML S/SU CONTAINED A MIX OF PRODUCTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "MISSING 01 BOX OF LOT 0133737 AND LEFTOVER OF 01 BOX OF SYRINGE DESC.03ML S / AG C / 1000 LL-BD OF LOT 0133655."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    876493 SYRINGE PLASTIPAK 3ML S/SU SYRINGE FMF BECTON DICKINSON IND. CIRURGICAS LTDA 0133655

    Patients

    Seq Age Sex Outcome Treatment
    1 Other