BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 3ML LL 21X1-1/2 EMERALD SLA

    MDR report key: 11198374 · Received January 19, 2021

    Report

    Report Number
    3003916417-2021-00010
    Event Type
    Malfunction
    Date Received
    January 19, 2021
    Date of Event
    December 28, 2020
    Report Date
    January 28, 2021
    Manufacturer
    BECTON DICKINSON IND. CIRURGICAS LTDA
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 0044598, MEDICAL DEVICE EXPIRATION DATE: 2025-02-28, DEVICE MANUFACTURE DATE: 2020-02-13. MEDICAL DEVICE LOT #: 7160540, MEDICAL DEVICE EXPIRATION DATE: 2022-06-30, DEVICE MANUFACTURE DATE: 2017-06-30. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Additional Manufacturer Narrative · 1

    INVESTIGATION: IT WAS PERFORMED THE DHR, MAINTENANCE RECORDS WERE PERFORMED AND QUALITY NOTIFICATIONS WERE CHECKED AND NO DEVIATIONS WERE FOUND FOR THIS BATCH. EVALUATING THE PHOTO AND THE CUSTOMER'S REPORT WAS NOT POSSIBLE TO VERIFY THE REPORTED INCIDENTS. FOR DEFECTS LIKE THIS ONE WE NEED PHYSICAL SAMPLES FOR A POSSIBLE CONFIRMATION. THE RETENTION SAMPLES WERE ALSO EVALUATED AND THE DEFECT WAS NOT FOUND. THE PRODUCTION PROCESSES ARE VALIDATED ACCORDING TO THE DEFINED ACCEPTANCE CRITERIA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SYRINGE 3ML LL 21X1-1/2 EMERALD SLA LEAKED PAST THE HUB CONNECTION DURING USE. THIS OCCURRED ONCE EACH IN LOTS 0044598 AND 7160540. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM SPANISH TO ENGLISH: "AT THE TIME OF ASPIRATING SALINE SOLUTION FOR DILUTION OF THE BNT162B2 VACCINE FOR SARS-COV 2, THE NEEDLE SHOWS RESISTANCE TO EXTRACT THE REQUIRED AMOUNT OF SOLVENT. ONCE EXTRACTED, IT IS INJECTED IN THE VIAL TO COMPLETE THE SOLUTION, AT WHICH TIME THE SOLUTION IS EXPELLED BY THE SYRINGE HUB, LOSING THE AMOUNT OF SOLVENT TO COMPLETE THE PREPARATION. NOT HAVING KNOWLEDGE OF THE EXACT VOLUME ENTERED INTO THE VIAL, IT WAS DECIDED TO ELIMINATE THE ENTIRE BOTTLE, LOSING 5 DOSES OF VACCINATION."

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SYRINGE 3ML LL 21X1-1/2 EMERALD SLA LEAKED PAST THE HUB CONNECTION DURING USE. THIS OCCURRED ONCE EACH IN LOTS 0044598 AND 7160540. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: "AT THE TIME OF ASPIRATING SALINE SOLUTION FOR DILUTION OF THE BNT162B2 VACCINE FOR SARS-COV 2, THE NEEDLE SHOWS RESISTANCE TO EXTRACT THE REQUIRED AMOUNT OF SOLVENT. ONCE EXTRACTED, IT IS INJECTED IN THE VIAL TO COMPLETE THE SOLUTION, AT WHICH TIME THE SOLUTION IS EXPELLED BY THE SYRINGE HUB, LOSING THE AMOUNT OF SOLVENT TO COMPLETE THE PREPARATION. NOT HAVING KNOWLEDGE OF THE EXACT VOLUME ENTERED INTO THE VIAL, IT WAS DECIDED TO ELIMINATE THE ENTIRE BOTTLE, LOSING 5 DOSES OF VACCINATION."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    89241 SYRINGE 3ML LL 21X1-1/2 EMERALD SLA PISTON SYRINGE FMF BECTON DICKINSON IND. CIRURGICAS LTDA SEE SECTION H.10.

    Patients

    Seq Age Sex Outcome Treatment
    1