BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEEDLE 19GA 1IN TW

    MDR report key: 10199718 · Received June 26, 2020

    Report

    Report Number
    1911916-2020-00585
    Event Type
    Malfunction
    Date Received
    June 26, 2020
    Date of Event
    June 9, 2020
    Report Date
    June 15, 2020
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMI
    UDI-DI
    30382903051862
    PMA / PMN Number
    K021475
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. (B)(4). INVESTIGATION SUMMARY: ONE PHOTO WAS PROVIDED FOR EVALUATION. THE PHOTO SHOWS FIVE PACKAGING BLISTERS TOP WEB. SINCE NO SAMPLES DISPLAYING THE CONDITION REPORTED ARE AVAILABLE FOR EXAMINATION, WE WERE UNABLE TO FULLY INVESTIGATE THIS INCIDENT. NO ROOT CAUSE CAN BE DETERMINED AS NO SAMPLES WERE RECEIVED. 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 NO SAMPLE, THE INVESTIGATION CONCLUDED, BD WAS NOT ABLE TO VERIFY THE INDICATED FAILURE. 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: THIS IS THE 1ST COMPLAINT FOR LOT # 22009 FOR THIS TYPE OF DEFECT OR SYMPTOM. THERE WAS NO DOCUMENTATION FOR THIS TYPE OF DEFECTS DURING THE ENTIRE PRODUCTION RUN OF THIS BATCH. BASED ON THE INVESTIGATION AND WITH NO SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER CAN¿T BE CONFIRMED NOR THIS SYMPTOM BE CORRELATED WITH A POTENTIAL CAUSE LINKED TO THE MANUFACTURING PROCESS. THIS IS THE 1ST COMPLAINT. THIS LOT WAS PRODUCED FOR 1.9MM UNITS; THIS IS A CPM OF 0.5; WE WILL CONTINUE MONITORING THE COMPLAINTS OF THIS PRODUCT AND LOT. ROOT CAUSE DESCRIPTION: BASED ON THE INVESTIGATION AND WITH NO SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER CAN¿T BE CONFIRMED NOR THIS SYMPTOM BE CORRELATED WITH A POTENTIAL CAUSE LINKED TO THE MANUFACTURING PROCESS. RATIONALE: CAPA NOT REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF NEEDLE 19GA 1IN TW EXPERIENCED LEAKAGE DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 305186, BATCH NO: 0022009. RECEIVED AN EMAIL FROM THE CUSTOMER, PROVIDING THE FOLLOWING INFORMATION. THE CUSTOMER CONFIRMED THEY ARE USING A BD NEEDLE. THE PHOTO SAMPLE WAS PROVIDED WITH REF305186. THE LEAKING WAS FOUND OUT WHEN THE NEEDLE WAS DRIPPING AFTER REMOVING THE NEEDLE FROM THE BAG THAT WAS BEING FILLED; THE CLAMP WAS OPEN. THE LOCATION OF THE DRIPPING WAS FROM THE TIP OF THE NEEDLE. NO FURTHER INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    667972 NEEDLE 19GA 1IN TW HYPODERMIC SINGLE LUMEN NEEDLE FMI BD MEDICAL (BD WEST) MEDICAL SURGICAL 305186 0022009 30382903051862

    Patients

    Seq Age Sex Outcome Treatment
    1 Other