BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK¿ SYRINGE

    MDR report key: 7982134 · Received October 18, 2018

    Report

    Report Number
    3003916417-2018-00274
    Event Type
    Malfunction
    Date Received
    October 18, 2018
    Date of Event
    September 28, 2018
    Report Date
    November 30, 2018
    Manufacturer
    BECTON DICKINSON IND. CIRURGICAS LTDA
    Product Code
    FMF
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: PHOTOS OF THE PRODUCT RECEIVED BY THE CUSTOMER WERE RECEIVED, HOWEVER THE PRODUCT BATCH AND CATALOG IS DIFFERENT FROM THE ORIGINAL ORDER MADE BY THE CUSTOMER. HOWEVER, THE ABSENCE OF BATCH INFORMATION OF THE MISSING QUANTITY - 3ML MAKES IT IMPOSSIBLE TO MORE ASSERTIVELY IDENTIFY THE MATERIAL FLOW FROM THE PRODUCTION ENVIRONMENT TO THE DELIVERY TO THE CUSTOMER. BASED ON THIS, IT WAS NOT POSSIBLE TO CONFIRM THE REPORTED DEFECT - CATALOG MIX AND LOWER QUANTITY RECEIPT COMPARED TO CATALOG STANDARD 990627 (300 UNITS). THE DHR, QUALITY NOTIFICATIONS AND MAINTENANCE RECORDS WERE PERFORMED IN WHICH IT WAS NOT POSSIBLE TO CONFIRM THE DEFECT OF PRODUCT MIX AND QUANTITY LESS THAN THE LOT ACQUIRED AND ALSO AS A BASIS FOR THE INFORMATION AVAILABLE TO INVESTIGATE THIS OCCURRENCE. IN ADDITION, ANALYSIS OF THE STERILIZED CATALOGS / LOTS WERE CARRIED OUT IN THE PERIOD - ONE WEEK INTERVAL, IN WHICH THE PRODUCT PLASTIPAK 5ML (8113930) WAS STERILIZED AND THE STERILIZATION OF THE 3ML CATALOG (990627) IN WHICH THERE COULD HAVE BEEN INCORRECT PALLETIZATION OR MIX DURING THE MANUFACTURING PROCESS. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED WITH THE USE OF THE BD PLASTIPAK¿ SYRINGE THERE WAS AN ISSUE WITH MIXED PRODUCT. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

    Additional Manufacturer Narrative · 1

    THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. (B)(6). 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 · 1

    IT WAS REPORTED WITH THE USE OF THE BD PLASTIPAK¿ SYRINGE THERE WAS AN ISSUE WITH MIXED PRODUCT. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    817382 BD PLASTIPAK¿ SYRINGE SYRINGE FMF BECTON DICKINSON IND. CIRURGICAS LTDA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other