BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ULTRASAFE PASSIVE¿ X-SERIES NEEDLE GUARD SYRINGE - X100L

    MDR report key: 15815047 · Received November 17, 2022

    Report

    Report Number
    3009081593-2022-00011
    Event Type
    Malfunction
    Date Received
    November 17, 2022
    Date of Event
    October 20, 2022
    Report Date
    November 9, 2022
    Manufacturer
    BECTON DICKINSON HUNGARY KFT (BD)
    Product Code
    MEG
    UDI-DI
    00382908607049
    PMA / PMN Number
    K122558
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 9240032, MEDICAL DEVICE EXPIRATION DATE: 31-JUL-2024, DEVICE MANUFACTURE DATE: 28-AUG-2019. MEDICAL DEVICE LOT #: 9247402, MEDICAL DEVICE EXPIRATION DATE: 31-AUG-2024, DEVICE MANUFACTURE DATE: 04-SEP-2019. MEDICAL DEVICE LOT #: 9338625, MEDICAL DEVICE EXPIRATION DATE: 30-NOV-2024, DEVICE MANUFACTURE DATE: 04-DEC-2019. MEDICAL DEVICE LOT #: 9298781, MEDICAL DEVICE EXPIRATION DATE: 30-SEP-2024, DEVICE MANUFACTURE DATE: 25-OCT-2019. MEDICAL DEVICE LOT #: 9333700, MEDICAL DEVICE EXPIRATION DATE: 31-OCT-2024, DEVICE MANUFACTURE DATE: 29-NOV-2019. INITIAL REPORTER PHONE#: UNKNOWN. INVESTIGATION SUMMARY: THE CUSTOMER ISSUED A COMPLAINT FOR DIFFICULT ACTIVATE PROBLEM DETECTED BY END USER. NO SAMPLE OR PHOTO WAS PROVIDED TO BD MEDICAL ¿ PHARMACEUTICAL SYSTEM (BDM-PS) FOR ANALYSIS. BASED ON THE DESCRIPTION BD ASSIGNED A QUALITY CRITERIA THAT IS RELATED TO THE REPORTED CONDITION AND IDENTIFIED IN THE AGREED SPECIFICATION. AFTER REVIEWING THE OCCURRENCE, IRRESPECTIVE OF ROOT CAUSE, IT IS WITHIN THE SPECIFICATION AND NO FURTHER ACTION WILL BE ASSIGNED. THE REPORT WILL NOT BE UPDATED IF THE SAMPLE IS RECEIVED AFTER THE APPROVAL OF THIS REPORT. AS THIS IS A MARKET EVENT, THE REPORTED CONDITION DETECTED IS NOT PART OF A SAMPLING PLAN THAT ALLOWS TO CONCLUDE ABOUT THE WHOLE BATCH, THEREFORE THE AQL IS NOT APPLICABLE. THE BATCH WAS MANUFACTURED AND RELEASED ACCORDING TO APPLICABLE PROCEDURES AND SPECIFICATIONS. CONSEQUENTLY, BDM-PS WILL NOT DEFINE CORRECTIVE OR PREVENTIVE ACTIONS FOLLOWING THE INVESTIGATION OF THIS COMPLAINT. THIS COMPLAINT IS REGISTERED IN BD COMPLAINT SYSTEM AND TREND ANALYSIS WILL BE PERFORMED. BASED ON INVESTIGATION CONCLUSION, BDM-PS WAS NOT ABLE TO CONFIRM THE SYMPTOM PERCEIVED BY CUSTOMER OR CORRELATE THIS SYMPTOM WITH A POTENTIAL CAUSE LINKED TO BD PROCESS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE USER HAD DIFFICULTY ACTIVATING THE SAFETY GUARD ON THE BD ULTRASAFE PASSIVE¿ X-SERIES NEEDLE GUARD SYRINGE - X100L. THIS OCCURRED ONCE EACH IN LOTS 9240032, 9247402, 9338625, 9298781, AND 9333700. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE ULTRASAFE WAS HARD TO GET TO ACTIVATE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    200339 BD ULTRASAFE PASSIVE¿ X-SERIES NEEDLE GUARD SYRINGE - X100L PISTON SYRINGE MEG BECTON DICKINSON HUNGARY KFT (BD) SEE H10 00382908607049

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown