BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRASAFE X225L PNG CLEAR

    MDR report key: 10389235 · Received August 11, 2020

    Report

    Report Number
    3009081593-2020-00082
    Event Type
    Malfunction
    Date Received
    August 11, 2020
    Date of Event
    July 8, 2020
    Report Date
    August 31, 2020
    Manufacturer
    BECTON DICKINSON HUNGARY KFT (BD)
    Product Code
    MEG
    PMA / PMN Number
    SEE H.10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: THE CUSTOMER ISSUED A COMPLAINT FOR A DISASSEMBLED DEVICE DETECTED BY END USER. PHOTOS WERE 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. BASED ON THE INVESTIGATION CONCLUSION, BDM-PS WAS NOT ABLE TO CONFIRM THE SYMPTOM PERCEIVED BY THE CUSTOMER OR CORRELATE THIS SYMPTOM WITH A POTENTIAL CAUSE LINKED TO BD PROCESS. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ULTRASAFE X225L PNG CLEAR WAS DISASSEMBLED. THIS WAS DISCOVERED AFTER USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE RECEIVED 2 CUSTOMER COMPLAINTS FOR AN ATYPICAL DEFECT ON DISASSEMBLED DEVICES IN 3 PARTS AS SHOWN ON ENCLOSED PICTURES.

    Additional Manufacturer Narrative · 1

    MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 0076684, MEDICAL DEVICE EXPIRATION DATE: 2025-02-28, DEVICE MANUFACTURE DATE: 2020-03-16. MEDICAL DEVICE LOT #: 0086626, MEDICAL DEVICE EXPIRATION DATE: 2025-02-28, DEVICE MANUFACTURE DATE: 2020-03-26. MEDICAL DEVICE LOT #: 0071417, MEDICAL DEVICE EXPIRATION DATE: 2025-02-28, DEVICE MANUFACTURE DATE: 2020-03-11. PMA/510(K)#: K011369, K122558. DEVICE EVALUATED BY MFR: 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 ULTRASAFE X225L PNG CLEAR WAS DISASSEMBLED. THIS WAS DISCOVERED AFTER USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE RECEIVED 2 CUSTOMER COMPLAINTS FOR AN ATYPICAL DEFECT ON DISASSEMBLED DEVICES IN 3 PARTS AS SHOWN ON PICTURES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    858644 ULTRASAFE X225L PNG CLEAR PISTON SYRINGE MEG BECTON DICKINSON HUNGARY KFT (BD) SEE H.10

    Patients

    Seq Age Sex Outcome Treatment
    1 Other