BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PRECISIONGLIDE¿ NEEDLE

    MDR report key: 8817578 · Received July 23, 2019

    Report

    Report Number
    1911916-2019-00724
    Event Type
    Malfunction
    Date Received
    July 23, 2019
    Date of Event
    June 16, 2019
    Report Date
    July 9, 2019
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMI
    UDI-DI
    30382903051107
    PMA / PMN Number
    K021475
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. INVESTIGATION SUMMARY: 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. EXAMINATION OF THE PRODUCT INVOLVED MAY PROVIDE CLARIFICATION AS TO THE CAUSE FOR THE REPORTED FAILURE. 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 REVIEW COULD NOT BE COMPLETED AS NO BATCH NUMBER WAS PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BEFORE USE IT WAS DISCOVERED THAT THE NEEDLE WAS CLOGGED AND WAS UNABLE TO DELIVER INSULIN WITH A BD PRECISIONGLIDE¿ NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE COMPANY REPORTER: IT WAS REPORTED THAT ON 06/16 THE NEEDLE WAS CLOGGED AND WOULD NOT ALLOW FOR THE INSULIN AND AIR TO BE PUSHED OUT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DESCRIPTION OF ISSUE: CUSTOMER REPORTED HAVING ISSUES WITH 2 NEEDLES GIVING PROBLEMS BEFORE ATTEMPTING FILLING THE CARTRIDGE WITH BEING DIFFICULT PUSHING THE INSULIN AND AIR OUT. CUSTOMER IS NOW LOW ON SUPPLIES AND REQUESTED REPLACEMENTS. DID THE CUSTOMER INSERT THE NEEDLE INTO THE CARTRIDGE AND ENCOUNTER FILL RESISTANCE? NO. PROCEED TO STEP 3. NUMBER OF OCCURRENCES: 2-WITHIN LAST MONTH, MOST RECENT OCCURRED LAST NIGHT ITEM NUMBER: 3 ML SYRINGE ¿ 309657; 26 G, 3/8¿ NEEDLE ¿ 305110. PRODUCT LOT NUMBER: FROM LAST NIGHT- 8172842. FOR BD PRODUCT ONLY, ARE SAMPLES AVAILABLE FOR INVESTIGATION? YES. DOES CUSTOMER AUTHORIZE BD TO CONTACT CUSTOMER TO OBTAIN SAMPLE(S)? NO. DID ISSUE CAUSE ANY INJURY? IF YES, WHAT TYPE OF INJURY? NO. MEDICAL INTERVENTION NEEDED? IF YES, WHO WAS THE 3RD PARTY AND WHAT WAS THE ASSISTANCE/TREATMENT? NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    608757 BD PRECISIONGLIDE¿ NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BD MEDICAL (BD WEST) MEDICAL SURGICAL UNKNOWN 30382903051107

    Patients

    Seq Age Sex Outcome Treatment
    1 Other