BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYR 3ML 22GA 1-1/4IN JPK/SIL NO ASSY NDL

    MDR report key: 8699859 · Received June 14, 2019

    Report

    Report Number
    9614033-2019-00166
    Event Type
    Malfunction
    Date Received
    June 14, 2019
    Date of Event
    May 30, 2019
    Report Date
    July 10, 2019
    Manufacturer
    BECTON DICKINSON DE MEXICO
    Product Code
    FMF
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: PHOTOS RECEIVE FOR INVESTIGATION. UPON OBSERVATION, INSIDE THE BLISTERPACK THERE IS A SCREW. THE LOTS WAS INSPECTED ACCORDING TO THE CURRENT WORK INSTRUCTION WITH SATISFACTORY RESULTS FOR THE CHARACTERISTICS REQUIRED FOR ITS APPROVAL INCLUDING FUNCTIONAL TESTS. NO NON-CONFORMING PART THAT COULD BE ATTRIBUTABLE TO THE DEFECT REPORTED BY THE CLIENT WAS PRESENTED. NO DEVIATIONS (QUALITY NOTIFICATIONS) WERE REPORTED DURING THE MANUFACTURING PROCESS. POSSIBLE ROOT CAUSE, WHEN THE ADJUSTMENT OF THE MACHINE WAS MADE, THE CYLINDER FEED HAS OPPRESSIVE SCREWS WHICH, THROUGH THE CONTINUOUS USE, COULD LOOSEN AND FALL TO THE BAND WHERE IT IS IN THE PRODUCT TO BE PACKAGED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SYR 3ML 22GA 1-1/4IN JPK/SIL NO ASSY NDL PACKAGING HAD A SCREW INSIDE IT. LOT #'S 9015772 AND 9015795 WERE REPORTED TO HAVE BEEN INVOLVED IN THIS EVENT, BUT IT IS UNKNOWN HOW MANY OCCURRENCES HAPPENED WITHIN EACH LOT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM SPANISH TO ENGLISH: "SYRINGE WITH OBJECTS INSIDE THE PACKAGE (A SCREW)."

    Additional Manufacturer Narrative · 1

    THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 9015772, MEDICAL DEVICE EXPIRATION DATE: 2024-01-12, DEVICE MANUFACTURE DATE: 2019-01-15. MEDICAL DEVICE LOT #: 9015795, MEDICAL DEVICE EXPIRATION DATE: 2024-01-31, DEVICE MANUFACTURE DATE: 2019-01-15. (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 THAT THE SYR 3ML 22GA 1-1/4IN JPK/SIL NO ASSY NDL PACKAGING HAD A SCREW INSIDE IT. LOT #'S 9015772 AND 9015795 WERE REPORTED TO HAVE BEEN INVOLVED IN THIS EVENT, BUT IT IS UNKNOWN HOW MANY OCCURRENCES HAPPENED WITHIN EACH LOT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: "SYRINGE WITH OBJECTS INSIDE THE PACKAGE (A SCREW)."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    492796 SYR 3ML 22GA 1-1/4IN JPK/SIL NO ASSY NDL SYRINGE FMF BECTON DICKINSON DE MEXICO SEE SECTION H.10.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other