BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ULTRASAFE PLUS X100L PNG CLEAR

    MDR report key: 8758329 · Received July 3, 2019

    Report

    Report Number
    3009081593-2019-00160
    Event Type
    Malfunction
    Date Received
    July 3, 2019
    Date of Event
    June 20, 2019
    Report Date
    July 17, 2019
    Manufacturer
    BECTON DICKINSON HUNGARY KFT (BD)
    Product Code
    MEG
    PMA / PMN Number
    K123743
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: NEITHER SAMPLE NOR 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 THE INVESTIGATION CONCLUSION THE DEFECT OCCURRED DUE TO MISUSE OF THE COMBINATION PRODUCT. THE IDENTIFIED POTENTIAL CAUSES FOR PLUNGER PULLED OUT ISSUES ARE ALL RELATED TO MISUSE/MISHANDLING OF THE COMBINATION PRODUCT BY THE END USER. BD IFU WHICH WAS PROVIDED TO OUR CUSTOMER IS DETAILED ENOUGH TO AVOID MISHANDLING DURING REMOVAL OF THE COMBINATION PRODUCT FROM BLISTER OR DURING PREPARATION OF THE PRODUCT FOR ADMINISTRATION. H3 OTHER TEXT : SEE H.10

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE,BUT PRIOR TO ACTIVATION THE MEDICATION SPILLED OUT WITH A BD ULTRASAFE PLUS X100L PNG CLEAR. THE SAFETY SHIELD ALSO DID NOT ACTIVATE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE PATIENT REPORTED WHEN WANTED TO APPLY THE DRUG THE WHOLE INJECTIONS SPILLED OUT FROM THE SYRINGE WITHOUT ACTIVATION OF THE AUTOMATIC NEEDLE GUARD AS THE PATIENT PUT THE DRUG OUT OF THE BLISTER.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 8233901; MEDICAL DEVICE EXPIRATION DATE: 2023-07-31; DEVICE MANUFACTURE DATE: 2018-08-21. MEDICAL DEVICE LOT #: 8205529; ;MEDICAL DEVICE EXPIRATION DATE: 2023-06-30; DEVICE MANUFACTURE DATE: 2018-07-24. INITIAL REPORTER PHONE #: UNKNOWN. 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 DURING USE,BUT PRIOR TO ACTIVATION THE MEDICATION SPILLED OUT WITH A BD ULTRASAFE PLUS X100L PNG CLEAR. THE SAFETY SHIELD ALSO DID NOT ACTIVATE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE PATIENT REPORTED WHEN WANTED TO APPLY THE DRUG THE WHOLE INJECTIONS SPILLED OUT FROM THE SYRINGE WITHOUT ACTIVATION OF THE AUTOMATIC NEEDLE GUARD AS THE PATIENT PUT THE DRUG OUT OF THE BLISTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    555180 BD ULTRASAFE PLUS X100L PNG CLEAR SYRINGE, ANTISTICK MEG BECTON DICKINSON HUNGARY KFT (BD) SEE H.10

    Patients

    Seq Age Sex Outcome Treatment
    1 Other