BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 10ML LL

    MDR report key: 10571418 · Received September 23, 2020

    Report

    Report Number
    3003152976-2020-00416
    Event Type
    Malfunction
    Date Received
    September 23, 2020
    Date of Event
    September 1, 2020
    Report Date
    October 13, 2020
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.10. DEVICE AVAILABLE FOR EVAL?: YES. D.10. RETURNED TO MANUFACTURER ON: 10/7/2020. H.6. INVESTIGATION: FIVE SAMPLES IN THEIR OPEN PACKAGE AND TEN SEALED SAMPLES WERE PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. THE PRODUCT WAS VISUALLY INSPECTED, THE BARRELS WERE OBSERVED TO BE PROPERLY LUBRICATED AND THERE WAS NO EVIDENCE OF EXCESS SILICONE OR ANY OTHER DEFECT ON THE PRODUCT. A DEVICE HISTORY REVIEW WAS PERFORMED FOR LOT 1910003, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THE REPORTED 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. BREAK OUT FORCE AND SUSTAINING FORCE TESTING ALONG WITH SILICONE CONTENT TESTS ARE PERFORMED DURING THE MANUFACTURING PROCESS OF EACH LOT NUMBER, RESULTS WERE REVIEWED FOR LOT 1910003 AND FOUND TO BE WITHIN SPECIFICATION. THE SAME TESTING WAS PERFORMED ON THE RETURNED SAMPLES AND ALL RESULTS WERE WITHIN REQUIRED LIMITS. 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. 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 SYRINGE 10ML LL HAD FOREIGN MATTER INSIDE. THIS WAS DISCOVERED BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: SORT OF STICKY SUBSTANCE VISIBLE WITHIN THE SYRINGES AND THE PLUNGER IS SLUGGISH. PER REP: THE CUSTOMER REPORTS THAT THEY HAVE IDENTIFIED 13 PRODUCTS WITH A ¿STICKY¿ SUBSTANCE WITHIN THE SYRINGE HOUSING. THE PRODUCTS ARE ALL UNUSED AND THE DISCOVERY WAS MADE DURING UNPACKING, THEREFORE NO CONTAMINATION. THERE HAVE BEEN NO ADVERSE EFFECTS.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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 SYRINGE 10 ML LL HAD FOREIGN MATTER INSIDE. THIS WAS DISCOVERED BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: SORT OF STICKY SUBSTANCE VISIBLE WITHIN THE SYRINGES AND THE PLUNGER IS SLUGGISH. PER REP: THE CUSTOMER REPORTS THAT THEY HAVE IDENTIFIED 13 PRODUCTS WITH A ¿STICKY¿ SUBSTANCE WITHIN THE SYRINGE HOUSING. THE PRODUCTS ARE ALL UNUSED AND THE DISCOVERY WAS MADE DURING UNPACKAGING, THEREFORE NO CONTAMINATION. THERE HAVE BEEN NO ADVERSE EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1041425 SYRINGE 10ML LL SYRINGE FMF BECTON DICKINSON, S.A. 1910003

    Patients

    Seq Age Sex Outcome Treatment
    1 Other