BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 50ML LL

    MDR report key: 10078974 · Received May 21, 2020

    Report

    Report Number
    3003152976-2020-00218
    Event Type
    Malfunction
    Date Received
    May 21, 2020
    Date of Event
    April 30, 2020
    Report Date
    June 11, 2020
    Manufacturer
    BECTON DICKINSON, S.A.
    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: D.10 DEVICE AVAILABLE FOR EVAL YES, RETURNED TO MANUFACTURER ON: 2020-06-05. H.6. INVESTIGATION SUMMARY TWO USED SAMPLES WERE RECEIVED FOR EVALUATION BY OUR QUALITY ENGINEER. THROUGH VISUAL INSPECTION OF THE SAMPLE, THERE WAS NO EVIDENCE A LEAK OCCURRED. LEAKAGE TESTING WAS PERFORMED ON THE SAMPLES, NO LEAKAGE WAS OBSERVED AND PRODUCTS MET REQUIRED SPECIFICATION. THE PRODUCT WAS DISASSEMBLED FOR FURTHER INSPECTION, THERE WAS NO DAMAGE OR MOLDING DEFECTS NOTED IN THE PLUNGER ROD OR OTHER COMPONENTS THAT COULD HAVE CAUSED A LEAK. THE STOPPER WAS PROPERLY ASSEMBLED TO THE PLUNGER IN BOTH SAMPLES THAT WERE EVALUATED. A DEVICE HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT 2002211, NO DEVIATIONS OR NON-CONFORMANCE'S WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. 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 AVAILABLE INFORMATION WE ARE NOT ABLE TO DETERMINE A ROOT CAUSE AT THIS TIME. COMPLAINTS RECEIVED FOR THIS DEFECT AND DEVICE WILL BE MONITORED BY OUR QUALITY TEAM FOR SIGNS OF EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SYRINGE 50ML LL LEAKED PAST THE STOPPER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "I WOULD LIKE TO MAKE A COMPLAINT ABOUT THE BD PLASTIPAK 50 ML SYRINGE. LIQUID LEAKS THROUGH THE RUBBER STOPPER WHEN USING SYRINGE. OUR PHARMACY ASSISTANTS INDICATE THAT THEY HAVE HAD THIS GOING ON MORE OFTEN IN RECENT WEEKS. WE USE THESE SYRINGES WHEN PREPARING CYTOSTATICS FOR ADMINISTRATION SO I PREFER NOT TO TAKE ANY RISKS WITH THIS. IN THE ATTACHMENT I HAVE ADDED A PHOTO WITH LOT NUMBER OF THE SYRINGE. I KEPT THE SYRINGE ITSELF, IN WHICH ONLY NACL 0.9% HAS BEEN DRAWN UP. IF YOU WOULD LIKE TO RECEIVE IT, PLEASE LET ME KNOW."

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SYRINGE 50ML LL LEAKED PAST THE STOPPER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "I WOULD LIKE TO MAKE A COMPLAINT ABOUT THE BD PLASTIPAK 50 ML SYRINGE. LIQUID LEAKS THROUGH THE RUBBER STOPPER WHEN USING SYRINGE. OUR PHARMACY ASSISTANTS INDICATE THAT THEY HAVE HAD THIS GOING ON MORE OFTEN IN RECENT WEEKS. WE USE THESE SYRINGES WHEN PREPARING CYTOSTATICS FOR ADMINISTRATION SO I PREFER NOT TO TAKE ANY RISKS WITH THIS. IN THE ATTACHMENT I HAVE ADDED A PHOTO WITH LOT NUMBER OF THE SYRINGE. I KEPT THE SYRINGE ITSELF, IN WHICH ONLY NACL 0.9% HAS BEEN DRAWN UP. IF YOU WOULD LIKE TO RECEIVE IT, PLEASE LET ME KNOW."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    541635 SYRINGE 50ML LL SYRINGE FMF BECTON DICKINSON, S.A. 2002211

    Patients

    Seq Age Sex Outcome Treatment
    1 Other