BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEEDLE NS 27GA 1IN BLT SQ GRD W/O SHLD

    MDR report key: 10193061 · Received June 24, 2020

    Report

    Report Number
    1911916-2020-00582
    Event Type
    Malfunction
    Date Received
    June 24, 2020
    Date of Event
    June 12, 2020
    Report Date
    June 18, 2020
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMI
    PMA / PMN Number
    K021475
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE EXPIRATION DATE: NA. (B)(4). INVESTIGATION SUMMARY: THE CUSTOMER PROVIDED NINE PHOTOS AND THREE SAMPLES FOR EVALUATION. THREE SAMPLES CAME IN A PLASTIC BAG; THEY DO NOT HAVE A PLASTIC SHIELD. THE SAMPLES ARE NUMBERED AT THE PLASTIC HUB AS 1,2, AND 3. A VISUAL INSPECTION WAS PERFORMED WITH A 10X MAGNIFIER LENS. NO DEFECT OBSERVED. ALSO, THE SAMPLES WERE INSPECTED UNDER THE MICROSCOPE; IT WAS IMPOSSIBLE TO OBSERVE THE REPORTED SYMPTOM. THEY WERE TAKEN FOR PICTURES WITH A 40X CAMERA. ONLY WITH THAT MAGNIFICATION, IT WAS POSSIBLE TO OBSERVE SOME DISCOLORATION AT THE NEEDLE TIP ON THE INNER DIAMETER. WITH A MAGNIFICATION, 40X OR HIGHER, MINOR DISCOLORATION COULD SEE POST GRINDING/CLEANING. THIS CONDITION COULD BE A RESULT OF THE RINSING PROCESS'S VARIATION, OR IT COULD BE INDUCED DURING OTHER PROCESSING DONE BY OTHER COMPANIES (IES) AFTER THE BD MANUFACTURING PROCESS IS COMPLETED. ALL PRODUCTS ARE INSPECTED FOR CLEANLINESS DURING THE PRODUCTION PROCESS. INVESTIGATION CONCLUSION: THIS IS THE 1ST COMPLAINT FOR LOT#: 9130963 FOR THIS TYPE OF DEFECT OR SYMPTOM. THERE WAS NO DOCUMENTATION FOR THIS TYPE OF DEFECTS DURING THE ENTIRE PRODUCTION RUN OF THIS BATCH. THIS LOT WAS PRODUCED FOR 0.480MM UNITS. THIS IS A CPM OF 2.0. WE WILL CONTINUE MONITORING AND TRENDING THIS LOT AND PRODUCT FOR THIS SYMPTOM ROOT CAUSE DESCRIPTION: BASED ON THE INVESTIGATION AND ANALYSIS OF THE SAMPLE RECEIVED, THE SYMPTOM REPORTED BY THE CUSTOMER HAS BEEN CONFIRMED; HOWEVER, THE SOURCE IS UNKNOWN. RATIONALE: CAPA NOT REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOREIGN MATTER WAS FOUND ON THE NEEDLE NS 27GA 1IN BLT SQ GRD W/O SHLD BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: TODAY OUR PRODUCTION TEAM IDENTIFIED FOREIGN MATERIAL (FM) ON THE 27 GA BLUNT CANNULAS. OUR IN-PROCESS INSPECTION CAUGHT THIS AT 20X MAGNIFICATION. INITIAL OBSERVATIONS ARE SHOWING THIS CONDITION ACROSS SEVERAL ORDERS USING THIS BATCH. WE ARE IN THE PROCESS OF GATHERING SAMPLES TO SEND FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    653116 NEEDLE NS 27GA 1IN BLT SQ GRD W/O SHLD HYPODERMIC SINGLE LUMEN NEEDLE FMI BD MEDICAL (BD WEST) MEDICAL SURGICAL 9130963

    Patients

    Seq Age Sex Outcome Treatment
    1 Other