BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PRECISIONGLIDE¿ HYPODERMIC NEEDLES

    MDR report key: 17375620 · Received July 22, 2023

    Report

    Report Number
    1911916-2023-00503
    Event Type
    Malfunction
    Date Received
    July 22, 2023
    Date of Event
    June 29, 2023
    Report Date
    September 27, 2023
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMI
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B.3. DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. H3. 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 HAVE BEEN UPDATED DUE TO ADDITIONAL INFORMATION: D.9. DEVICE AVAILABLE FOR EVAL?: YES. D.9. RETURNED TO MANUFACTURER ON: 22-SEP-2023. H.6. INVESTIGATION SUMMARY: IT WAS REPORTED AT THE TIME OF PUNCTURE THE SOLUTION DOES NOT COME OUT. TO AID IN THE INVESTIGATION, THREE SAMPLES WITH NO PACKAGING BLISTERS AND ONE VIDEO WAS PROVIDED FOR EVALUATION BY OUR QUALITY TEAM. A VISUAL INSPECTION WAS PERFORMED, AND NO DEFECTS OR IMPERFECTIONS WERE OBSERVED. EACH SAMPLE WAS THEN CONNECTED TO A SYRINGE WITH SALINE SOLUTION. IT WAS NOT POSSIBLE TO EXPEL THE SOLUTION; THE NEEDLES ARE CLOGGED. THE VIDEO PROVIDED SHOWS A NEEDLE BEING TAKEN FROM THE PACKAGING BLISTER, CONNECTED TO A SYRINGE AND THEN AN ATTEMPT TO EXPEL THE SOLUTION. IN THE VIDEO, IT APPEARS THE PACKAGING BLISTER TOP WEB IS DAMAGED, SIMILAR TO WHEN THE NEEDLE HUB IS PUSHED THROUGH THE TOP WEB. WHEN OPENING THE PACKAGING BY PUSHING THE UNIT THROUGH THE TOP WEB, THIS CAN INDUCE FOREIGN MATTER INTO THE NEEDLE AND CLOGGING CAN OCCUR. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 305108, LOT 2020909. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION OF THIS LOT THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. THERE WERE NO RELATED QUALITY NOTIFICATIONS. ALL PROCESSES AND FINAL INSPECTIONS COMPLIED WITH SPECIFICATION REQUIREMENTS. THERE ARE QUALITY CONTROLS CURRENTLY IN PLACE TO DETECT THIS TYPE OF DEFECT DURING THE PRODUCTION PROCESS SUCH AS A VISION SYSTEM THAT INSPECTS 100% OF ALL PRODUCTS FOR CLOGGED NEEDLES. BASED ON THE INVESTIGATION AND WITH THE RETURNED SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER IS CONFIRMED. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD PRECISIONGLIDE¿ HYPODERMIC NEEDLES THE NEEDLE SOLUTION WAS NOT COMING OUT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM SPANISH TO ENGLISH: WE REPORT PRODUCTS THAT ARE COMING OUT IMPERFECT BECAUSE NOTHING COMES OUT AT THE TIME OF THE PUNCTURE. . UNFORTUNATELY, THIS PRODUCT IS COMING OUT IMPERFECT, AT THE TIME OF PUNCTURE THE SOLUTION DOES NOT COME OUT, IN THE FIRST PURCHASE WE HAD TO DISCARD ALMOST HALF A BOX. ON THIS OCCASION WE VERBALLY INFORM YOU WHERE PROOF WAS DELIVERED TO ONE OF THE WORKERS OF THIS COMPANY, AND AGAIN THE SAME THING IS HAPPENING TO US WITH THE SECOND PURCHASE."

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD PRECISIONGLIDE¿ HYPODERMIC NEEDLES THE NEEDLE SOLUTION WAS NOT COMING OUT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM SPANISH TO ENGLISH: WE REPORT PRODUCTS THAT ARE COMING OUT IMPERFECT BECAUSE NOTHING COMES OUT AT THE TIME OF THE PUNCTURE. . UNFORTUNATELY, THIS PRODUCT IS COMING OUT IMPERFECT, AT THE TIME OF PUNCTURE THE SOLUTION DOES NOT COME OUT, IN THE FIRST PURCHASE WE HAD TO DISCARD ALMOST HALF A BOX. ON THIS OCCASION WE VERBALLY INFORM YOU WHERE PROOF WAS DELIVERED TO ONE OF THE WORKERS OF THIS COMPANY, AND AGAIN THE SAME THING IS HAPPENING TO US WITH THE SECOND PURCHASE"

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1922564 BD PRECISIONGLIDE¿ HYPODERMIC NEEDLES HYPODERMIC SINGLE LUMEN NEEDLE FMI BD MEDICAL (BD WEST) MEDICAL SURGICAL 2020909

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown