BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEEDLE NS 23GA 3/4IN W/O SIL

    MDR report key: 10900782 · Received November 25, 2020

    Report

    Report Number
    1911916-2020-01058
    Event Type
    Malfunction
    Date Received
    November 25, 2020
    Date of Event
    October 12, 2020
    Report Date
    January 1, 2021
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMI
    PMA / PMN Number
    K021475
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR PROVIDED LOT NUMBER 71338. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THIS REPORTED INCIDENT. TO AID IN THE INVESTIGATION OF THIS INCIDENT, ONE PHYSICAL SAMPLE AND ONE PICTURE SAMPLE WAS RECEIVED BY OUR QUALITY TEAM FOR INSPECTION. THE SAMPLE CAME WITH THE PLASTIC SHIELD AND A VISUAL INSPECTION WAS PERFORMED WITH NAKED EYE FINDING NO DEFECTS NOR DAMAGES. THE SAMPLE WAS THEN INSPECTED WITH A 30X MICROSCOPE HAVING THE SAME RESULTS. THE SAMPLE WAS THEN MEASURED FOR ID BY USING CALIBRATED WIRE, THIS IS A GO/NO GO GAUGE. IT WAS CONFIRMED THAT IT IS A 23 GAUGE WITH 0.0125". THE PICTURE PROVIDED LOOKS IT WAS TAKEN FROM THE BOTTOM PART OF THE NEEDLE HUB TOWARDS THE NEEDLE. IT SHOWS THAT THE NEEDLE HUB CENTER EDGE AND WHERE THE BOTTOM PART OF NEEDLE JOINS IS NOT UNIFORM. IT SEEMS THIS PHOTO WAS TAKEN WITH A 1000+ MAGNIFICATION. THE ROOT CAUSE FOR THIS DEFECT COULD NOT BE DETERMINED. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT NEEDLE NS 23GA 3/4IN W/O SIL HAD FLASH DETECTED. THIS OCCURRED ON 60000 OCCASIONS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 301687, BATCH NO.: 0071338. IT WAS REPORTED THAT THERE WAS FLASH DETECTED WITHIN THE CANNULA. PER EMAIL: WE RECENTLY HAD THE FOLLOWING PART FAIL INSPECTION. THE SPECIFICATION CALLS FOR .0125 (+.0015/-.0000) INNER DIAMETER BUT IT MEASURED .0121 WITH THERE BEING FLASH DETECTED ON THE PRODUCT.

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE EXPIRATION DATE: NA. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT NEEDLE NS 23GA 3/4IN W/O SIL HAD FLASH DETECTED. THIS OCCURRED ON 60000 OCCASIONS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 301687 BATCH NO.: 0071338. IT WAS REPORTED THAT THERE WAS FLASH DETECTED WITHIN THE CANNULA. PER EMAIL: WE RECENTLY HAD THE FOLLOWING PART FAIL INSPECTION. THE SPECIFICATION CALLS FOR .0125 (+.0015/-.0000) INNER DIAMETER BUT IT MEASURED .0121 WITH THERE BEING FLASH DETECTED ON THE PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1372156 NEEDLE NS 23GA 3/4IN W/O SIL HYPODERMIC SINGLE LUMEN NEEDLE FMI BD MEDICAL (BD WEST) MEDICAL SURGICAL 0071338

    Patients

    Seq Age Sex Outcome Treatment
    1