BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD PRECISIONGLIDE¿ NEEDLE

    MDR report key: 15859270 · Received November 23, 2022

    Report

    Report Number
    1911916-2022-00676
    Event Type
    Injury
    Date Received
    November 23, 2022
    Date of Event
    October 18, 2022
    Report Date
    November 26, 2022
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMI
    UDI-DI
    00382903051281
    PMA / PMN Number
    K021475
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVALUTION?: YES. D10: RETURNED TO MANUFACTURER ON: 30-NOV-2022 H6: INVESTIGATION SUMMARY IT WAS REPORTED A NEEDLE BROKEN INSIDE A PATIENT. TO AID IN THE INVESTIGATION, NINETY-NINE SAMPLES IN SEALED PACKAGING BLISTERS WERE RECEIVED FOR EVALUATION BY OUR QUALITY TEAM. EACH SAMPLE WAS VISUALLY INSPECTED. FIRST, WITH A 10X MAGNIFIER LENS, AND THEN WITH A 30X MICROSCOPE. NO DAMAGES, MARKS OR ANY OTHER CONDITION THAT COULD INDUCE NEEDLE BREAKAGE WAS OBSERVED. TWO REPORTS WERE ALSO PROVIDED. ONE STATED THE PATIENT HAD A NEEDLE IN THE BODY AND THE OTHER AFTER THE REMOVAL OF IT. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 305128, LOT NUMBER 2020908. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION OF THIS LOT THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. TO DATE, THERE HAVE BEEN NO OTHER SIMILAR EVENTS REPORTED FOR THIS LOT. BASED ON THE INVESTIGATION AND WITH THE RETURNED SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER COULD NOT BE CONFIRMED, AND A PROBABLE ROOT CAUSE COULD NOT BE OFFERED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD PRECISIONGLIDE¿ NEEDLE BROKE FROM THE HUB INTO THE PATIENT DURING THE ANESTHETIC INJECTION. AS A RESULT, THE PATIENT REQUIRED AN X-RAY AND EXCISION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "NEEDLE BROKE OFF FROM THE HUB IN THE PATIENT WHILE THEY WERE USING ANESTHETIC." "THE NEEDLE WAS LEFT IN THE PATIENT UPON DISCHARGE FROM THE OFFICE (B)(6) 2022. AN X-RAY WAS PERFORMED TO CONFIRM THE FOREIGN BODY, FOLLOWED BY AN EXCISION."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD PRECISIONGLIDE¿ NEEDLE BROKE FROM THE HUB INTO THE PATIENT DURING THE ANESTHETIC INJECTION. AS A RESULT, THE PATIENT REQUIRED AN X-RAY AND EXCISION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "NEEDLE BROKE OFF FROM THE HUB IN THE PATIENT WHILE THEY WERE USING ANESTHETIC." "THE NEEDLE WAS LEFT IN THE PATIENT UPON DISCHARGE FROM THE OFFICE (B)(6)2022. AN X-RAY WAS PERFORMED TO CONFIRM THE FOREIGN BODY, FOLLOWED BY AN EXCISION."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1917780 BD PRECISIONGLIDE¿ NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BD MEDICAL (BD WEST) MEDICAL SURGICAL 2020908 00382903051281

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention