BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PRECISIONGLIDE¿ NEEDLE

    MDR report key: 9696317 · Received February 11, 2020

    Report

    Report Number
    1911916-2020-00136
    Event Type
    Malfunction
    Date Received
    February 11, 2020
    Date of Event
    January 27, 2020
    Report Date
    January 31, 2020
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMI
    UDI-DI
    30382903051251
    PMA / PMN Number
    K021475
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: 134 SAMPLE WERE RECEIVED. THEY CAME IN SEALED PACKAGING BLISTER. 32 SAMPLES WERE VISUALLY INSPECTED FINDING NO DEFECTS. THEY WERE TESTED FOR CANNULA PULL TEST. THE VALUES WERE FROM 4.7LB TO 10.8LB. THE SPECIFICATION IS >3LBS. TWO PHOTOS WERE PROVIDED. THEY SHOW A NEEDLE OUT OF HUB. EVEN THOUGH THE FAILURE MODE IN RETURNED SAMPLES WAS NOT CONFIRMED, BASED ON THE PHOTO WE CAN CONFIRM IT. IT COULD BE POSSIBLE THAT NOT ENOUGH WHITE EPOXY WAS APPLIED TO THE JOINT, MAKING IT POSSIBLE FOR THE NEEDLE TO BE PULLED OUT OF THE HUB. 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. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED WITH ZERO DEFECTS FOUND. NO QUALITY NOTIFICATIONS WERE WRITTEN FOR THIS BATCH, NOR FOR THE ASSOCIATED ASSEMBLY BATCHES. INVESTIGATION CONCLUSION: CONFIRMED: BD WAS ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER'S INDICATED FAILURE MODE WITH THE SAMPLE PROVIDED. THIS IS THE 1ST COMPLAINT FOR LOT # 9193555 FOR THIS TYPE OF DEFECT OR SYMPTOM. THERE WAS NO DOCUMENTATION FOR THIS TYPE OF DEFECTS DURING THE ENTIRE PRODUCTION RUN OF THIS BATCH. ROOT CAUSE DESCRIPTION: IT COULD BE POSSIBLE THAT NOT ENOUGH WHITE EPOXY WAS APPLIED TO THE JOINT, MAKING IT POSSIBLE FOR THE NEEDLE TO BE PULLED OUT OF THE HUB. RATIONALE: CAPA NOT REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BD PRECISIONGLIDE¿ NEEDLE PULLED OUT OF THE HUB WHILE ADMINISTERING AN IM INJECTION OF IPV ON THE PATIENT'S LEFT THIGH. THE NEEDLE WAS REMOVED WITH THE NURSE'S FINGERS. THIS COMPLAINT WAS CREATED TO CAPTURE THE 1ST OF 2 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WHEN THE CUSTOMER ADMINISTERED IM INJECTION OF IPV ON L THIGH TO THE PATIENT, THE NEEDLE DETACHED FROM THE BLUE PART OF THE SYRINGE AND STAYED IN THE PT'S THIGH AS THE SYRINGE WAS PULLED BACK AFTER INJECTING THE VACCINE. THE NURSE CAREFULLY REMOVED THE NEEDLE WITH HER FINGERS AND APPLIED A BANDAID TO THE INJECTION SITE. THERE WAS SOME BLEEDING, WHICH STOPPED AFTER APPLYING PRESSURE FOR A FEW MOMENTS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    160459 BD PRECISIONGLIDE¿ NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BD MEDICAL (BD WEST) MEDICAL SURGICAL 305125 9193555 30382903051251

    Patients

    Seq Age Sex Outcome Treatment
    1 Other