BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 20ML LL NS

    MDR report key: 11032530 · Received December 17, 2020

    Report

    Report Number
    2243072-2020-02081
    Event Type
    Malfunction
    Date Received
    December 17, 2020
    Date of Event
    November 19, 2020
    Report Date
    December 21, 2020
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES, D10: RETURNED TO MANUFACTURER ON: 2020-12-14. H6: INVESTIGATION SUMMARY TWO SAMPLES AND TWO PHOTOS WERE PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. THROUGH VISUAL INSPECTION, FOREIGN MATTER IS OBSERVED IN THE PLUNGER NERVES OF THE FIRST SAMPLE AND THE THUMB PROCESS WAS OBSERVED TO BE BROKEN ON THE SECOND SAMPLE. USING MAGNIFICATION ON THE FIRST SAMPLE, THE MATTER WAS IDENTIFIED TO BE GREASE. A DEVICE HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOTS 1912351 AND 2001353, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THESE FAILURES. FINAL PRODUCTS IN THIS MANUFACTURING LINE, FOR THIS REFERENCE ARE SAMPLED AND THEY ARE SUBJECTED TO VISUAL AND FUNCTIONAL INSPECTIONS DURING THE DIFFERENT MANUFACTURING SUB-PROCESSES ACCORDING TO PROCEDURES. MANUFACTURING FOR THIS PRODUCT IS PERFORMED IN A CLEAN ROOM WHICH IS KEPT UNDER A POSITIVE PRESSURE TO REDUCE THE CHANCE OF FOREIGN MATTER. MANUFACTURING EQUIPMENT UNDERGOES ROUTINE MAINTENANCE AND CLEANING. THE AREAS WHERE PIECES MOVE WITHIN MANUFACTURING AREA ARE PROTECTED TO AVOID DAMAGE ON THE PRODUCT. WHILE WE COULD NOT IDENTIFY A DIRECT ISSUE FOR EITHER FAILURE, THE GREASE LIKELY ACCUMULATED WITHIN THE CHAMBER OF THE PLUNGER MOLD, PERSONNEL NOT PROPERLY CLEANING THE MOLD AND THE BROKEN THUMB PRESS WAS A RESULT OF THE PRODUCT JAMMING WITHIN THE MANUFACTURING EQUIPMENT. MANUFACTURING PERSONNEL HAVE BEEN NOTIFIED OF THESE INCIDENTS TO INCREASE AWARENESS. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT TWO SYRINGE 20ML LL NS HAD MALFUNCTIONS BEFORE USE: ONE WITH FOREIGN MATTER AND THE OTHER WITH PLUNGER DAMAGE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "I WOULD LIKE TO REPORT A COMPLAINT REGARDING ARTICLE 302055. ONE SYRINGE CONTAINS DIRT AND ANOTHER SYRINGE HAS A PART OF THE TOP OF THE PLUNGER BROKEN OFF."

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT TWO SYRINGE 20ML LL NS HAD MALFUNCTIONS BEFORE USE: ONE WITH FOREIGN MATTER AND THE OTHER WITH PLUNGER DAMAGE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "I WOULD LIKE TO REPORT A COMPLAINT REGARDING ARTICLE (B)(4). ONE SYRINGE CONTAINS DIRT AND ANOTHER SYRINGE HAS A PART OF THE TOP OF THE PLUNGER BROKEN OFF."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1496114 SYRINGE 20ML LL NS PISTON SYRINGE FMF BECTON DICKINSON UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1