BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PRECISIONGLIDE NEEDLE 26G X 3/8 IN

    MDR report key: 10554520 · Received September 18, 2020

    Report

    Report Number
    1911916-2020-00873
    Event Type
    Malfunction
    Date Received
    September 18, 2020
    Date of Event
    August 14, 2020
    Report Date
    September 3, 2020
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMI
    UDI-DI
    30382903051107
    PMA / PMN Number
    K021475
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INITIAL REPORTER OCCUPATION: SR. GLOBAL POST MARKET SURVEILLANCE SPECIALIST. (B)(4). INVESTIGATION SUMMARY: A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR PROVIDED LOT NUMBER 9193538. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THIS REPORTED INCIDENT. AS A SAMPLE WAS UNAVAILABLE FOR RETURN, A THOROUGH SAMPLE INVESTIGATION COULD NOT BE COMPLETED. BASED ON THE INVESTIGATION RESULTS, AN EXACT CAUSE FOR THIS INCIDENT COULD NOT BE IDENTIFIED. FURTHER ACTION HAS NOT BEEN DETERMINED NECESSARY AT THIS TIME. OUR QUALITY TEAM WILL CONTINUE TO MONITOR THE MANUFACTURING PROCESS FOR THIS DEFECT AND OTHER EMERGING TRENDS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BD PRECISIONGLIDE¿ NEEDLE 26 G X 3/8 IN EXPERIENCED A NEEDLE THAT BROKE DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DISTRIBUTOR RECEIVED EMAIL THROUGH IN CONTACT. CUSTOMER STATED SHE WAS HAVING TROUBLE WITH LOADING THE INSULIN INTO HER CARTRIDGE AND THE NEEDLE BROKE OFF. DISTRIBUTOR FOLLOWED UP WITH CUSTOMER AND DOCUMENTED THE FOLLOWING: CALLER REPORTED FILL RESISTANCE ISSUE. NUMBER OF OCCURRENCES: 1. DID THE CALLER INSERT THE NEEDLE INTO THE CARTRIDGE AND ENCOUNTER FILL RESISTANCE? YES. PRODUCT WITH ISSUE: BD 26 G, 3/8" NEEDLE, PN 305110. NEEDLE LOT #: 9193538. CUSTOMER'S BG AT TIME OF EVENT: SPECIFIC VALUE IS UNKNOWN BUT BG REMAINED BETWEEN 54-500MG/DL (3.0-27.7 MMOL/L), NO FURTHER BG QUESTIONS REQUIRED. DOES INSULIN COME OUT OF THE EXISTING NEEDLE? N/A, ISSUE HAPPENED IN THE PAST. CUSTOMER HAD ALREADY CHANGED NEEDLE AND SYRINGE AT TIME OF CALL. WERE THEY ABLE TO FILL THE EXISTING CARTRIDGE WITH THE SECOND NEEDLE? NO. RESOLUTION: CALLER WAS ABLE TO SUCCESSFULLY FILL A SECOND CARTRIDGE WITH A SECOND NEEDLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1021947 BD PRECISIONGLIDE NEEDLE 26G X 3/8 IN HYPODERMIC SINGLE LUMEN NEEDLE FMI BD MEDICAL (BD WEST) MEDICAL SURGICAL 305110 9193538 30382903051107

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Other