BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 30ML LL

    MDR report key: 11198330 · Received January 19, 2021

    Report

    Report Number
    3003152976-2021-00041
    Event Type
    Malfunction
    Date Received
    January 19, 2021
    Date of Event
    December 10, 2020
    Report Date
    February 19, 2021
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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: 2020-12-23. H6: INVESTIGATION SUMMARY: NINE SEALED SAMPLES OF LOT 2001238, NINETEEN SEALED SAMPLES OF LOT 2001239, AND THREE PHOTOS HAVE BEEN PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. UPON VISUAL INSPECTION OF THE PHOTOS, NO SIGNS OF EXCESS SILICONE CAN BE OBSERVED INSIDE THE SYRINGE. A DEVICE HISTORY REVIEW WAS PERFORMED FOR REPORTED LOTS 2001238 AND 2001239, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. 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 LOTS 2001238 AND 2001239 AND FOUND TO BE WITHIN SPECIFICATION. TESTING WAS PERFORMED ON THE RETURNED SAMPLES, RESULTS VERIFIED AMOUNT OF SILICONE WAS WITH THE REQUIRED LIMITS. BASED ON THE INVESTIGATION RESULTS, NO MANUFACTURING RELATED DEFECTS COULD BE IDENTIFIED AND THEREFORE, A CAUSE FOR THE REPORTED INCIDENT COULD NOT BE DETERMINED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 50 SYRINGE 30ML LL HAD LIQUID IN THE SYRINGE BEFORE USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "OILY RESIDUE IN SYRINGE IT WAS REPORTED THAT THE CUSTOMER HAS IDENTIFIED AN OILY RESIDUE IN THE MAJORITY OF THE SYRINGES IN THE BOX.:

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 50 SYRINGE 30ML LL HAD LIQUID IN THE SYRINGE BEFORE USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "OILY RESIDUE IN SYRINGE IT WAS REPORTED THAT THE CUSTOMER HAS IDENTIFIED AN OILY RESIDUE IN THE MAJORITY OF THE SYRINGES IN THE BOX.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    88663 SYRINGE 30ML LL PISTON SYRINGE FMF BECTON DICKINSON, S.A. 2001239

    Patients

    Seq Age Sex Outcome Treatment
    1