BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRASAFE X100L PNG CLEAR SDZ

    MDR report key: 9857621 · Received March 19, 2020

    Report

    Report Number
    3009081593-2020-00027
    Event Type
    Malfunction
    Date Received
    March 19, 2020
    Date of Event
    February 26, 2020
    Report Date
    March 30, 2020
    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

    INVESTIGATION SUMMARY: CONFIRMED, NOT PART OF SPECIFICATION. INVESTIGATION CONCLUSION: THE CUSTOMER ISSUED A COMPLAINT FOR A DEFECTIVE SAFETY DEVICE DETECTED DURING PRODUCTION PROCESS. NEITHER SAMPLE NOR PHOTO WAS PROVIDED TO BD MEDICAL ¿ PHARMACEUTICAL SYSTEMS (BDM-PS) FOR ANALYSIS. THERE IS NO CRITERIA IN THE SPECIFICATION FOR THIS CRITERIA. 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 AS NOT PART OF THE APPLICABLE SPECIFICATION. AS A CONSEQUENCE BDM-PS DEFINES PREVENTIVE ACTION FOLLOWING THE INVESTIGATION OF THIS COMPLAINT BASED ON POTENTIAL IS ROOT CAUSE LINKED TO BDM-PS PROCESS. ROOT CAUSE DESCRIPTION: 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 AS NOT PART OF THE APPLICABLE SPECIFICATION. RATIONALE: COMPLAINT IS CONFIRMED AS NOT PART OF SPECIFICATION AND PREVENTIVE ACTIONS WERE DEFINED IN REPORT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ULTRASAFE X100L PNG CLEAR SDZ WAS DEFECTIVE. THIS WAS DISCOVERED ON 9 OCCASIONS BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: 9 DEVICES DID NOT COMPLY WITH THE FUNCTIONALITY RELATED TO DIAMETER. THERE IS A LACK OF ACCURACY RELATED TO THE INNER DIAMETER.

    Additional Manufacturer Narrative · 1

    PMA/510(K)#: K011369, K122558. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ULTRASAFE X100L PNG CLEAR SDZ WAS DEFECTIVE. THIS WAS DISCOVERED ON 9 OCCASIONS BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: 9 DEVICES DID NOT COMPLY WITH THE FUNCTIONALITY RELATED TO DIAMETER. THERE IS A LACK OF ACCURACY RELATED TO THE INNER DIAMETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321316 ULTRASAFE X100L PNG CLEAR SDZ PISTON SYRINGE MEG BECTON DICKINSON HUNGARY KFT (BD) 9323153

    Patients

    Seq Age Sex Outcome Treatment
    1 Other