BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRASAFE X225L PR WHITE SSL

    MDR report key: 10752038 · Received October 28, 2020

    Report

    Report Number
    3001741852-2020-00043
    Event Type
    Malfunction
    Date Received
    October 28, 2020
    Date of Event
    October 7, 2020
    Report Date
    November 9, 2020
    Manufacturer
    BECTON DICKINSON
    Product Code
    MEG
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: THE CUSTOMER ISSUED A COMPLAINT FOR SAFETY DEVICE UNABLE TO ACTIVATE DETECTED BY END USER. ONE PICTURE EVIDENCES WAS PROVIDED TO BD MEDICAL: PHARMACEUTICAL SYSTEM (BDM-PS) FOR ANALYSIS. THESE ULTRASAFE PLUNGER ROD PRODUCTS ARE MANUFACTURED AT BD APPROVED SUPPLIER AND RELEASED BASED ON CERTIFICATE COMPLIANCE. THE 8D TEAM LEADER PERFORMED A RELEASE PAPERWORK REVIEW: BOTH REPORTED BATCHES MEET ALL ACCEPTABLE QUALITY LEVELS (AQL¿S), WERE MANUFACTURED AND RELEASED ACCORDING TO APPLICABLE PROCEDURES AND SPECIFICATIONS. THE IN-PROCESS DIMENSIONAL INSPECTION AND VISUAL INSPECTION'S (800 UNITS PER BATCH) RESULTS ALL PASSED. THE REPORTED CONDITION COULD BE LINKED TO END USER ERROR AND IFU NOT FOLLOWED: BASED ON PICTURE EVIDENCE PROVIDED BY THE CUSTOMER, THE PLUNGER COULD NOT HAVE BEEN PUSHED DEEP ENOUGH FOR THE TRIGGER FINGERS TO BE TRIGGERED. THE DETAILS OF THE CUSTOMER IFU CANNOT BE VERIFIED AND IS BEYOND THE SCOPE OF THIS INVESTIGATION. THE TRIGGERING AND ACTIVATION CYCLE TEST PERFORMED BY TATABANYA'S PLANT ON NEEDLE GUARD RETAIN SAMPLES ALSO INDICATE A POTENTIAL END USER ERROR. BASED ON THE INVESTIGATION CONCLUSION, BDM-PS DOES NOT PROPOSE ANY CORRECTIVE OR PREVENTIVE ACTION IN THE SCOPE OF THIS COMPLAINT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE USER COULD NOT ACTIVATE THE ULTRASAFE X225L PR WHITE SSL SAFETY GUARD AFTER USE. THIS OCCURRED 1 TIME IN LOT 1913020, AND AN UNSPECIFIED NUMBER OF TIMES IN LOT 1905203. THIS COMPLAINT WAS CREATED TO CAPTURE THE 2ND OF 2 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "AS PART OF A CUSTOMER COMPLAINT, A PATIENT REPORTED THAT THE SAFETY SAFETY ULTRASAFE DID NOT ACTIVATE"

    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 #: 1913020, MEDICAL DEVICE EXPIRATION DATE: 2024-10-09, DEVICE MANUFACTURE DATE: (B)(6) 2019. MEDICAL DEVICE LOT #: 1905203, MEDICAL DEVICE EXPIRATION DATE: 2024-09-19, DEVICE MANUFACTURE DATE: (B)(6) 2019. 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 THE USER COULD NOT ACTIVATE THE ULTRASAFE X225L PR WHITE SSL SAFETY GUARD AFTER USE. THIS OCCURRED 1 TIME IN LOT 1913020, AND AN UNSPECIFIED NUMBER OF TIMES IN LOT 1905203. THIS COMPLAINT WAS CREATED TO CAPTURE THE 2ND OF 2 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "AS PART OF A CUSTOMER COMPLAINT, A PATIENT REPORTED THAT THE SAFETY SAFETY ULTRASAFE DID NOT ACTIVATE"

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1214291 ULTRASAFE X225L PR WHITE SSL ANTISTICK SYRINGE MEG BECTON DICKINSON SEE SECTION H.10.

    Patients

    Seq Age Sex Outcome Treatment
    1