BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    22 G X 1 1/2 IN. BD INTEGRA¿ NEEDLE

    MDR report key: 6956157 · Received October 17, 2017

    Report

    Report Number
    1911916-2017-00270
    Event Type
    Malfunction
    Date Received
    October 17, 2017
    Date of Event
    September 21, 2017
    Report Date
    February 1, 2018
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    MEG
    UDI-DI
    30382903053132
    PMA / PMN Number
    K011103
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION RESULTS: FIVE REPRESENTATIVE NEEDLES WITH CONNECTION (HUBS) WERE RETURNED TO THE (B)(4) PLANT FOR EVALUATION. THE PACKAGES WERE NOT OPENED. PRODUCT IS WITHIN SPECIFICATION. REPRESENTATIVES WERE LEAK TESTED AND THERE WAS NO LEAKAGE BETWEEN CONNECTION OF THE SYRINGE AND NEEDLE. DHR WAS PERFORMED: 305313/5212683 CONVERT TO 8000599/5212549 WAS PRODUCED ON 11/12/15 WITH ZERO DEFECTS FOUND. CONCLUSION: ROOT CAUSE COULD NOT BE IDENTIFIED USING REPRESENTATIVE SAMPLES. WITHOUT ACTUAL NEEDLE AND ACTUAL SYRINGE USED WE WERE UNABLE TO CONFIRM COMPLAINT. NO ADDITIONAL CORRECTIVE ACTION IS REQUIRED AT THIS TIME.

    Additional Manufacturer Narrative · 1

    (B)(6). IT IS UNKNOWN IF A SAMPLE WILL BE RETURNED FOR EVALUATION. HOWEVER, A NO SAMPLE INVESTIGATION AND DEVICE HISTORY RECORD REVIEW WILL BE COMPLETED. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CONNECTION OF THE 22 G X 1 1/2 IN. BD INTEGRA" NEEDLE AND THE SYRINGE WERE LOOSE CAUSING THE FLUID TO LEAK. THERE WAS NO REPORT OF EXPOSURE, INJURY OR MEDICAL INTERVENTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    733667 22 G X 1 1/2 IN. BD INTEGRA¿ NEEDLE SAFETY ENGINEERED HYPODERMIC NEEDLE MEG BD MEDICAL (BD WEST) MEDICAL SURGICAL 5212683 30382903053132

    Patients

    Seq Age Sex Outcome Treatment
    1 Other