BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PRECISIONGLIDE NEEDLE 26G X 3/8 IN

    MDR report key: 10171986 · Received June 18, 2020

    Report

    Report Number
    1911916-2020-00559
    Event Type
    Malfunction
    Date Received
    June 18, 2020
    Date of Event
    May 13, 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

    INITIAL REPORTER OCCUPATION: SR. GLOBAL POST MARKET SURVEILLANCE SPECIALIST. (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 IDENTIFICATION OF EMERGING TRENDS. BASED ON NO SAMPLE, THE INVESTIGATION CONCLUDED, BD WAS NOT ABLE TO VERIFY THE INDICATED FAILURE. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED WITH ZERO DEFECTS FOUND. NO QUALITY NOTIFICATIONS WERE WRITTEN FOR THIS BATCH, NOR FOR THE ASSOCIATED ASSEMBLY BATCHES. INVESTIGATION CONCLUSION: THIS IS THE 2ND COMPLAINT FOR LOT # 9212458 FOR THIS TYPE OF DEFECT OR SYMPTOM. THERE WAS NO DOCUMENTATION FOR THIS TYPE OF DEFECT DURING THE ENTIRE PRODUCTION RUN OF THIS BATCH. ROOT CAUSE DESCRIPTION: BASED ON THE INVESTIGATION AND WITH NO SAMPLE TO ANALYZE OR PHOTO SHOWING THE SYMPTOM REPORTED BY THE CUSTOMER, THE SYMPTOM CAN¿T BE CONFIRMED. NO ADDITIONAL ACTIONS WILL BE TAKEN OTHER THAN MONITORING THE COMPLAINT TREND FOR THIS LOT. RATIONALE: CAPA NOT REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF BD PRECISIONGLIDE¿ NEEDLES 26G X 3/8 IN EXPERIENCED LEAKAGE AT THE CONNECTION SITE DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 305110 BATCH NO. 9212458. COMPLAINT 4 OF 4. PER CUSTOMER EMAIL: CALLER REPORTED LEAKING AT THE BASE OF THE NEEDLE WHERE IT CONNECTS TO THE SYRINGE WHEN PUSHING DOWN ON THE SYRINGE PLUNGER. NUMBER OF OCCURRENCES: 3. 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. PRODUCT LOT # 9212458. DID ISSUE CAUSE ANY INJURY? NO. DID CUSTOMER REQUIRE MEDICAL INTERVENTION? NO. IS PRODUCT MANUFACTURED BY BD? YES, SAMPLE IS AVAILABLE FOR INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    636027 BD PRECISIONGLIDE NEEDLE 26G X 3/8 IN HYPODERMIC SINGLE LUMEN NEEDLE FMI BD MEDICAL (BD WEST) MEDICAL SURGICAL 305110 9212458 30382903051107

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Other