BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRASAFE X100L PNG CLEAR SDZ

    MDR report key: 8750286 · Received July 1, 2019

    Report

    Report Number
    3009081593-2019-00158
    Event Type
    Malfunction
    Date Received
    July 1, 2019
    Date of Event
    June 14, 2019
    Report Date
    August 13, 2019
    Manufacturer
    BECTON DICKINSON HUNGARY KFT (BD)
    Product Code
    MEG
    PMA / PMN Number
    SEE H.10.
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: 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 THE INVESTIGATION CONCLUSION, BDM-PS WAS ABLE TO CONFIRM THE DETECTION AND CHARACTERIZE THE CONDITION REPORTED BY THE CUSTOMER. THE REPORTED CONDITION, HAS BEEN CONFIRMED TO BE OUT THE SPECIFIED ACCEPTABLE QUALITY LEVEL (AQL¿S) DEFINED IN THE APPLICABLE SPECIFICATION. GLOBAL CAPA HAS BEEN OPENED # (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE MATERIAL NUMBER ON THE ULTRASAFE X100L PNG CLEAR SDZ SHIPPING LABEL WAS INCORRECT, READING 46154883 RATHER THAN 46154833. THE DEFECT WAS NOTICED BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DURING SAMPLING OF MATERIAL ULTRASAFE X100L PNG CLEAR SDZ (BATCH 9052823/31828423) WE NOTICED AN ERROR ON THE SHIPPING LABEL. THE MATERIAL NUMBER IS NOT CORRECT. IT IS WRITTEN 46154883 INSTEAD OF 46154833.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. THERE WERE MULTIPLE PMA / 510(K)#S REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH 510(K) NUMBER IS AS FOLLOWS: PMA / 510(K)#: K011369, PMA / 510(K)#: 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 MATERIAL NUMBER ON THE ULTRASAFE X100L PNG CLEAR SDZ SHIPPING LABEL WAS INCORRECT, READING 46154883 RATHER THAN 46154833. THE DEFECT WAS NOTICED BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DURING SAMPLING OF MATERIAL ULTRASAFE X100L PNG CLEAR SDZ (BATCH 9052823/31828423) WE NOTICED AN ERROR ON THE SHIPPING LABEL. THE MATERIAL NUMBER IS NOT CORRECT. IT IS WRITTEN 46154883 INSTEAD OF 46154833.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    544148 ULTRASAFE X100L PNG CLEAR SDZ PISTON SYRINGE MEG BECTON DICKINSON HUNGARY KFT (BD) 9052823

    Patients

    Seq Age Sex Outcome Treatment
    1 Other