BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRASAFE X100L PR GREY SSL SDZ

    MDR report key: 8995267 · Received September 11, 2019

    Report

    Report Number
    3001741852-2019-00044
    Event Type
    Malfunction
    Date Received
    September 11, 2019
    Date of Event
    August 26, 2019
    Report Date
    December 18, 2019
    Manufacturer
    BECTON DICKINSON
    Product Code
    MEG
    PMA / PMN Number
    SEE H.10
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: TEN PICTURES 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. IN JUNE 2017, PACKAGING MATERIAL SPECIFICATION (PMS) 1539 REV. 2 WAS SIGNED BETWEEN BDM-PS AND SANDOZ. THIS PMS REQUESTED A CHANGE ABOUT LABELLING APPLIED ON BOXES, BUT WAS NOT INTERNALLY TRANSMITTED TO IMPLEMENT THIS CHANGE IN INTERNAL BDM-PS SPECIFICATIONS AND PROCEDURES, SUCH AS CUSTOMER SPECIFICATION. AS A CONSEQUENCE, BDM-PS CONFIRMED TO BE IN SPECIFICATION AS PER THE CUSTOMER SPECIFICATION SC000124 REV. 8. FROM PMS POINT OF VIEW, BDM-PS CONFIRMED TO BE OUT OF SPECIFICATION FOR SANDOZ MATERIAL NUMBER, BUT DOES NOT CONFIRM TO BE OUT OF SPECIFICATION FOR ARTICLE DESCRIPTION BECAUSE THIS REPORTED CONDITION IS NOT SPECIFIED. CHANGE IS COMPLETED AT BDM-PS AND SUPPLIER AND WILL BE IMPLEMENTED ON NEXT BATCHES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE ULTRASAFE X100L PR GREY SSL SDZ EXPERIENCED NO LABEL OR MISSING LABEL INFORMATION WHICH WAS NOTED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MISSING LABEL ON SHIPPING BOX AND MISSING MATERIAL NUMBER.

    Additional Manufacturer Narrative · 1

    PMA/510(K) #: K011369, K060743, K122558. 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 ULTRASAFE X100L PR GREY SSL SDZ EXPERIENCED NO LABEL OR MISSING LABEL INFORMATION WHICH WAS NOTED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MISSING LABEL ON SHIPPING BOX AND MISSING MATERIAL NUMBER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    794573 ULTRASAFE X100L PR GREY SSL SDZ SYRINGE, ANTISTICK MEG BECTON DICKINSON 1864435

    Patients

    Seq Age Sex Outcome Treatment
    1 Other