BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD ULTRA-FINE¿ PEN NEEDLE

    MDR report key: 8039834 · Received November 5, 2018

    Report

    Report Number
    9616656-2018-00246
    Event Type
    Injury
    Date Received
    November 5, 2018
    Date of Event
    October 9, 2018
    Report Date
    December 3, 2018
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    PMA / PMN Number
    K131358
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: CUSTOMER RETURNED ( 2 ) 4MM, 32G BD PEN NEEDLES WITHOUT THE TEAR DROP LABEL. CONSUMER STATES NEEDLE BROKE OFF IN STOMACH. ALL RETURNED PEN NEEDLES WERE EXAMINED AND NEITHER RETURNED PEN NEEDLE WERE BENT NOR BROKEN ON EITHER END OF THE CANNULA. BOTH RETURNED PEN NEEDLES WERE OK AT BOTH ENDS; THEY WERE BOTH TESTED FOR FLOW AND BOTH PASSED THE FLOW TEST SUCCESSFULLY. BOTH RETURNED PEN NEEDLES WERE ALSO TESTED FOR POINT GEOMETRY, OUTER DIAMETER AND LUBE COVERAGE. THE FOLLOWING WAS OBSERVED (SPECS: OUTER DIAMETER FOR 32G: 0.0090¿- 0.0095¿): DATA: POINT (PE/NPE), OUTER DIAMETER (IN) LUBE; SAMPLE 1: GOOD/GOOD, 0.0092, GOOD. SAMPLE 2: GOOD/GOOD, 0.0093, GOOD. A LOT HISTORY REVIEW WAS CARRIED OUT AND NO RELATED NON CONFORMANCES WERE RAISED IN ASSOCIATION WITH THIS PACKAGED LOT CONCLUDING ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS AND MET QC SPECIFICATIONS. SEVERITY: S_3__; OCCURRENCE: A COMPLAINT HISTORY CHECK WAS PERFORMED AND THIS IS THE 1ST RELATED COMPLAINT REPORTED FOR THE DEFECT/CONDITION ON LOT NUMBER 8045792. BASED ON THE SAMPLES / PHOTO(S) RECEIVED THE INVESTIGATION CONCLUDED: UNCONFIRMED: BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. BASED ON THE ABOVE, NO ADDITIONAL INVESTIGATION AND NO CAPA IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED WITH THE USE OF THE BD ULTRA-FINE¿ PEN NEEDLE THERE WAS AN ISSUE WITH NEEDLE BROKE OFF IN PATIENT¿S STOMACH. AMBULANCE WAS CALLED FOR A HOSPITAL TRIP AND NEEDLE WAS REMOVED WITH TWEEZERS.

    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 WITH THE USE OF THE BD ULTRA-FINE¿ PEN NEEDLE, THERE WAS AN ISSUE WITH NEEDLE BROKE OFF IN PATIENT¿S STOMACH. AMBULANCE WAS CALLED FOR A HOSPITAL TRIP AND NEEDLE WAS REMOVED WITH TWEEZERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    877186 BD ULTRA-FINE¿ PEN NEEDLE PEN NEEDLE FMI BECTON DICKINSON AND CO. 8045792

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention