BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PRECISIONGLIDE NEEDLE

    MDR report key: 10126556 · Received June 6, 2020

    Report

    Report Number
    1911916-2020-00531
    Event Type
    Malfunction
    Date Received
    June 6, 2020
    Date of Event
    May 30, 2020
    Report Date
    June 2, 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

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. (B)(6). (B)(4). 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. 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 THE IDENTIFICATION OF EMERGING TRENDS. BASED ON NO SAMPLE, THE INVESTIGATION CONCLUDED, BD WAS NOT ABLE TO VERIFY THE INDICATED FAILURE. HOWEVER, IT IS RECOMMENDED THAT THE HYPODERMIC PLATFORM MARKETING SHOULD CONTACT THE CUSTOMER TO EXPLAIN/CONFIRM THE PROPER USAGE OF THE NEEDLE ASSEMBLY. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED WITH ZERO DEFECTS FOUND. NO QUALITY NOTIFICATIONS WERE WRITTEN FOR THIS BATCH, NOR THE ASSOCIATED ASSEMBLY BATCHES. INVESTIGATION CONCLUSION: THIS IS THE 3RD COMPLAINT FOR LOT # 9212458 FOR FOREIGN MATTER. PREVIOUS COMPLAINT (B)(4). THIS IS THE 1ST COMPLAINT FOR INSERTION DIFFICULT, LEAKAGE (OTHER) AND ASPIRATE/DRAW (CANNOT/DIFFICULT). THERE WAS NO DOCUMENTATION FOR THIS TYPE OF DEFECTS DURING THE ENTIRE PRODUCTION RUN OF THIS BATCH. RATIONALE: CAPA NOT REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD PRECISIONGLIDE¿ NEEDLES EXPERIENCED ONE CASE OF FOREIGN MATTER CONTAMINATION, AND SEVEN CASES OF LEAKAGE AT THE CONNECTION SITE. PRODUCT DEFECTS WERE NOTED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: COMPLAINT 1 OF 2. VERBATIM: CALLER REPORTED SEVERAL INSTANCES WHERE THE CUSTOMERS NEEDLES WOULD NOT FIT PROPERLY IN THE BASE OF THE SYRINGE. CUSTOMER NOTED LOSING INSULIN AND HAVING DIFFICULTY PULLING INSULIN THROUGH DUE TO THERE BEING NO SEAL AT THE BASE OF THE SYRINGE. CUSTOMER ALSO NOTED RECEIVING ONE NEEDLE THAT UPON OPENING WAS COVERED IN A WHITE CRUSTY RESIDUE. CALLER COULD NOT VERIFY EXACT EVENT DATE, CALLER STATED THE EVENTS OCCURRED OVER THE PAST 2 MONTHS. NUMBER OF OCCURRENCES - 7 TIMES OVER A 2 MONTH PERIOD. WHITE CRUST COVERED NEEDLE ONLY OCCURRED ONCE. DID THE CALLER INSERT THE NEEDLE INTO THE CARTRIDGE AND ENCOUNTER FILL RESISTANCE? - NO. PRODUCT WITH ISSUE - BD 26 G, 3/8" NEEDLE, PN 305110. PRODUCT LOT # - 9212458. DID ISSUE CAUSE ANY INJURY? - NO. DID CUSTOMER REQUIRE MEDICAL INTERVENTION? - NO. RESOLUTION: CALLER WAS ABLE TO SUCCESSFULLY FILL A CARTRIDGE FOR ALL OF THE EVENTS. NO FURTHER ACTION REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    590162 BD PRECISIONGLIDE NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BD MEDICAL (BD WEST) MEDICAL SURGICAL 305110 9212458 30382903051107

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Other