BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PRECISIONGLIDE NEEDLE

    MDR report key: 10505845 · Received September 8, 2020

    Report

    Report Number
    3003916417-2020-00262
    Event Type
    Malfunction
    Date Received
    September 8, 2020
    Date of Event
    August 17, 2020
    Report Date
    September 23, 2020
    Manufacturer
    BECTON DICKINSON IND. CIRURGICAS LTDA
    Product Code
    FMI
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR MATERIAL NUMBER: 990193 AND LOT NUMBER: 911278. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THESE REPORTED DEFECTS. TO AID IN THE INVESTIGATION, THREE PHOTOS WERE PROVIDED FOR EVALUATION BY OUR QUALITY TEAM. THE THREE PHOTOS SHOW THE PACKAGING TOP WEB AND THREE NEEDLE ASSEMBLIES WITH THE PLASTIC SHIELD OUT OF THE PACKAGING BLISTER. AS A SAMPLE WAS UNAVAILABLE FOR RETURN, A THOROUGH SAMPLE INVESTIGATION COULD NOT BE COMPLETED. BASED ON THE INVESTIGATION CARRIED OUT AND WITH THE PHOTO SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER COULD NOT BE CONFIRMED. H3 OTHER TEXT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 3 BD PRECISIONGLIDE¿ NEEDLES WERE CLOGGED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM PORTUGUESE TO ENGLISH: "THE CUSTOMER GOT IN TOUCH TO BE ABLE TO COMPLAIN BECAUSE HE HAS NOTICED A DEVIATION IN THE QUALITY OF THE NEEDLE. HE REPORTS THAT IT HAS OCCURRED SEVERAL TIMES BUT ONLY TODAY HE TOOK THE TIME TO COME AND REPORT THESE EVENTS. THE NEEDLE WOULD BE CLOGGED AT ALL TIMES AND THERE WERE ALSO TIMES WHEN THE THREAD WAS MISSING. HE INFORMS THAT IN THE BOX BEFORE THIS ONE THE SAME THING HAPPENED AND LAST MONTH TOO."

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. (B)(6). A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 3 BD PRECISION GLIDE NEEDLES WERE CLOGGED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: "THE CUSTOMER GOT IN TOUCH TO BE ABLE TO COMPLAIN BECAUSE HE HAS NOTICED A DEVIATION IN THE QUALITY OF THE NEEDLE. HE REPORTS THAT IT HAS OCCURRED SEVERAL TIMES BUT ONLY TODAY HE TOOK THE TIME TO COME AND REPORT THESE EVENTS. THE NEEDLE WOULD BE CLOGGED AT ALL TIMES AND THERE WERE ALSO TIMES WHEN THE THREAD WAS MISSING. HE INFORMS THAT IN THE BOX BEFORE THIS ONE THE SAME THING HAPPENED AND LAST MONTH TOO."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    970108 BD PRECISIONGLIDE NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON IND. CIRURGICAS LTDA 9112781

    Patients

    Seq Age Sex Outcome Treatment
    1 Other