BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 3ML LL 200 S/C

    MDR report key: 12346300 · Received August 19, 2021

    Report

    Report Number
    9614033-2021-00097
    Event Type
    Malfunction
    Date Received
    August 19, 2021
    Date of Event
    July 22, 2021
    Report Date
    January 21, 2022
    Manufacturer
    BECTON DICKINSON DE MEXICO
    Product Code
    FMF
    UDI-DI
    30382903096573
    PMA / PMN Number
    K980987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: PHOTO RECEIVED FOR INVESTIGATION. UPON VISUAL INSPECTION, MATERIAL CONTENT LABEL IS DISPLAYED, IT IS NOT POSSIBLE TO OBSERVE THE FAILURE. A DEVICE HISTORY RECORD REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION OF THE PROVIDED LOT NUMBER THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. LUBRICANT IS EMPLOYED DURING THE SYRINGE ASSEMBLY PROCESS TO LUBRICATE THE CYLINDERS IN THE SILICONE STATION. THE SILICONE EMPLOYED IN THIS PRODUCT IS A MEDICAL GRADE SILICONE AUTHORIZED FOR PRODUCT USE. SILICONE CONTENT TESTS ARE PERFORMED DURING THE MANUFACTURING PROCESS OF EACH LOT NUMBER. RESULTS WERE REVIEWED FOR LOT 0161773 AND FOUND TO BE WITHIN SPECIFICATION. BASED ON THE AVAILABLE INFORMATION WE ARE NOT ABLE TO IDENTIFY A ROOT CAUSE RELATED TO THE MANUFACTURING PROCESS AT THIS TIME. PHYSICAL SAMPLES OR PHOTOS DISPLAYING THE FAILURE IS REQUIRED TO ANALYZE AND CONFIRM THE FAILURE.

    Description of Event or Problem · 0

    IT WAS REPORTED SYRINGE 3ML LL 200 S/C HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "SOME 3 ML B-D SYRINGES SEEM TO HAVE MORE LUBRICANT PRESENT INSIDE THE SYRINGE TO HELP THE PLUNGER SLIDE."

    Additional Manufacturer Narrative · 1

    INITIAL REPORTER ZIP: (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 SYRINGE 3ML LL 200 S/C HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "SOME 3 ML B-D SYRINGES SEEM TO HAVE MORE LUBRICANT PRESENT INSIDE THE SYRINGE TO HELP THE PLUNGER SLIDE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1243097 SYRINGE 3ML LL 200 S/C PISTON SYRINGE FMF BECTON DICKINSON DE MEXICO 309657 0161773 30382903096573

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown