BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NDLE 18GA 1-1/2IN BLT FILL NC TW SHLD

    MDR report key: 9879331 · Received March 25, 2020

    Report

    Report Number
    3002682307-2020-00112
    Event Type
    Malfunction
    Date Received
    March 25, 2020
    Date of Event
    February 26, 2020
    Report Date
    March 31, 2020
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMI
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR PROVIDED FINAL LOT NUMBER 191127. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THIS REPORTED INCIDENT AND ALL INSPECTIONS WERE FOUND TO BE WITHIN SPECIFICATION. TO FURTHER INVESTIGATE THIS ISSUE, ONE PHYSICAL SAMPLE AND ONE PICTURE SAMPLE WERE PROVIDED FOR EVALUATION BY OUR QUALITY ENGINEER TEAM. THROUGH EXAMINATION OF THE PICTURE SAMPLE AND PHYSICAL SAMPLE, A GREY PARTICLE WAS OBSERVED WITHIN THE SYRINGE; HOWEVER, NO DEFECTS WERE OBSERVED ON THE NEEDLE. AS THERE ARE SEVERAL OTHER FACTORS THAT CAN CONTRIBUTE TO CORING, INCLUDING STOPPER CONDITIONS AND HANDLING TECHNIQUES, AN EXACT CAUSE FOR THIS INCIDENT RELATED TO THE MANUFACTURING PROCESS COULD NOT BE IDENTIFIED. AT THIS TIME, FURTHER ACTION HAS NOT BEEN DETERMINED NECESSARY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF NDLE 18GA 1-1/2IN BLT FILL NC TW SHLD EXPERIENCED FOREIGN MATTER IN OR ON DEVICE CANNULA/NEEDLE/CORING. PRODUCT DEFECT WAS NOTED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE RETRACTABLE CANNULA CUT / PRICKED A PIECE OF RUBBER OUT OF THE RUBBERIZED CAP OF THE VIAL OF THE DRUG (PANTOZOL I.V. 40 MG). UNFORTUNATELY, IT GOT INTO THE SYRINGE. THE FOREIGN IN THE SYRINGE WAS NOTICED BY THE NURSE AFTER MIXED LIQUID. THE SAMPLE CANNULA IN QUESTION WAS USED FOR THE ASPIRATION OF A HARMLESS MEDICATION BUT DIDN¿T HAVE ANY CONTACT WITH BLOOD.

    Additional Manufacturer Narrative · 1

    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 AN UNSPECIFIED NUMBER OF NDLE 18GA 1-1/2IN BLT FILL NC TW SHLD EXPERIENCED FOREIGN MATTER IN OR ON DEVICE CANNULA/NEEDLE/CORING. PRODUCT DEFECT WAS NOTED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE RETRACTABLE CANNULA CUT / PRICKED A PIECE OF RUBBER OUT OF THE RUBBERIZED CAP OF THE VIAL OF THE DRUG (PANTOZOL I.V. 40 MG). UNFORTUNATELY, IT GOT INTO THE SYRINGE. THE FOREIGN IN THE SYRINGE WAS NOTICED BY THE NURSE AFTER MIXED LIQUID. THE SAMPLE CANNULA IN QUESTION WAS USED FOR THE ASPIRATION OF A HARMLESS MEDICATION BUT DIDN¿T HAVE ANY CONTACT WITH BLOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    345003 NDLE 18GA 1-1/2IN BLT FILL NC TW SHLD NEEDLE FMI BECTON DICKINSON, S.A. 191127

    Patients

    Seq Age Sex Outcome Treatment
    1 Other