BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRASAFE X100L PNG TEAL NVS STEIN

    MDR report key: 9979710 · Received April 20, 2020

    Report

    Report Number
    3009081593-2020-00040
    Event Type
    Malfunction
    Date Received
    April 20, 2020
    Date of Event
    December 23, 2019
    Report Date
    April 22, 2020
    Manufacturer
    BECTON DICKINSON HUNGARY KFT (BD)
    Product Code
    FMF
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: THE CUSTOMER ISSUED A COMPLAINT FOR A DETACHED NEEDLE GUARD PROBLEM DETECTED BY END USER. A PHOTO WAS PROVIDED TO BD MEDICAL ¿ PHARMACEUTICAL SYSTEM (BDM-PS) FOR ANALYSIS. BDM-PS PERFORMED A BATCH HISTORY RECORD¿S REVIEW (BHR) INCLUDING A REVIEW OF ALL DATA COLLECTED DURING IN PROCESS AND QUALITY INSPECTIONS. THE BATCHES INVOLVED IN THIS COMPLAINT MEET ALL ACCEPTABLE QUALITY LEVELS (AQL¿S), WERE MANUFACTURED AND RELEASED ACCORDING TO APPLICABLE PROCEDURES AND SPECIFICATIONS. BASED ON INVESTIGATION CONCLUSION A SYRINGE CAN ONLY BECOME DETACHED IF SYRINGE CAPTURE FEATURES OR THE FLANGE OF THE SYRINGE GET DAMAGED/BROKEN OR IF THE SYRINGE RECEIVES AN IMPACT AFTER SYRINGE INSERTION WHICH CAUSES IT TO UNCLIP FROM THE DEVICE. THEREFORE, THE SYRINGE MOST LIKELY BECAME DETACHED AS IT WAS NOT CLIPPED INTO THE DEVICE PROPERLY OR IT RECEIVED AN EXTERNAL IMPACT AFTER SYRINGE INSERTION WHICH CAUSED IT TO UNCLIP FROM THE DEVICE. NONE OF THESE CAUSES ARE RELATED TO BD PROCESS. INVESTIGATION WAS CONDUCTED WITH PICTURES/ANALYSIS REPORT PROVIDED BY THE CUSTOMER WITHOUT NEED OF PHYSICAL SAMPLE PROVIDED BY THE CUSTOMER. H3 OTHER TEXT : SEE SECTION H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SAFETY DEVICE SEPARATED FROM THE ULTRASAFE X100L PNG TEAL NVS STEIN BEFORE USE. LOT# 8051590 WAS REPORTED TO HAVE HAD 1 OCCURRENCE OF THIS EVENT, WHILE LOT# 8016559 WAS REPORTED TO HAVE HAD AN UNSPECIFIED NUMBER OF OCCURRENCES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ¿SYRINGE DETACHES FROM NSD".

    Additional Manufacturer Narrative · 1

    THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 8051590. MEDICAL DEVICE EXPIRATION DATE: 2023-01-31. DEVICE MANUFACTURE DATE: 2018-02-20. MEDICAL DEVICE LOT #: 8016559. MEDICAL DEVICE EXPIRATION DATE: 2022-12-31. DEVICE MANUFACTURE DATE: 2018-01-16. 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 THAT THE SAFETY DEVICE SEPARATED FROM THE ULTRASAFE X100L PNG TEAL NVS STEIN BEFORE USE. LOT# 8051590 WAS REPORTED TO HAVE HAD 1 OCCURRENCE OF THIS EVENT, WHILE LOT# 8016559 WAS REPORTED TO HAVE HAD AN UNSPECIFIED NUMBER OF OCCURRENCES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ¿SYRINGE DETACHES FROM NSD".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    439698 ULTRASAFE X100L PNG TEAL NVS STEIN PISTON SYRINGE FMF BECTON DICKINSON HUNGARY KFT (BD) SEE SECTION H.10.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other