BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD DISCARDIT II 2 ML SYRINGE

    MDR report key: 10668506 · Received October 13, 2020

    Report

    Report Number
    3002682307-2020-00306
    Event Type
    Malfunction
    Date Received
    October 13, 2020
    Date of Event
    September 17, 2020
    Report Date
    January 5, 2021
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR PROVIDED LOT NUMBER 2001123 AND THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THIS REPORTED INCIDENT. AS SAMPLES WERE NOT RETURNED FOR THIS INCIDENT, TWENTY RETAINED SAMPLES OF THE SAME LOT NUMBER WERE OBTAINED FROM THE MANUFACTURING FACILITY FOR FURTHER INVESTIGATION. THE RETAINED SAMPLES WERE INSPECTED AND NO SIGNS OF DEFECT WERE OBSERVED. BASED ON THE INVESTIGATION RESULTS AN EXACT CAUSE RELATED TO THE MANUFACTURING PROCESS COULD NOT BE IDENTIFIED FOR THIS INCIDENT. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF BD DISCARDIT¿ II 2 ML SYRINGES EXPERIENCED LEAKAGE DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER REPORTS THAT DURING THE START OF ANASTHESIA, THE PATIENT WAS ADMINISTERED LIDOCAINE WITH A 2 ML DISCARDIT SYRINGE. THE SYRINGE LEAKED AND MORE THAN HALF OF THE LIDOKCAINE CAME OUT. A NEW SYRINGE HAD TO BE TAKEN FOR PROCEEDING WITH THE ANASTHESIA. THIS IS NOT THE FIRST TIME THIS PROBLEM HAS OCCURED WITH THE SAME BATCH.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF BD DISCARDIT¿ II 2 ML SYRINGES EXPERIENCED LEAKAGE DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER REPORTS THAT DURING THE START OF ANESTHESIA, THE PATIENT WAS ADMINISTERED LIDOCAINE WITH A 2 ML DISCARDIT SYRINGE. THE SYRINGE LEAKED AND MORE THAN HALF OF THE LIDOKCAINE CAME OUT. A NEW SYRINGE HAD TO BE TAKEN FOR PROCEEDING WITH THE ANESTHESIA. THIS IS NOT THE FIRST TIME THIS PROBLEM HAS OCCURED WITH THE SAME BATCH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1134177 BD DISCARDIT II 2 ML SYRINGE SYRINGE FMF BECTON DICKINSON, S.A. 2001123

    Patients

    Seq Age Sex Outcome Treatment
    1 Other