BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEEDLE PRECISIONGLIDE 30X1/2IN

    MDR report key: 8845680 · Received July 31, 2019

    Report

    Report Number
    3003916417-2019-00363
    Event Type
    Malfunction
    Date Received
    July 31, 2019
    Date of Event
    July 12, 2019
    Report Date
    September 12, 2019
    Manufacturer
    BECTON DICKINSON IND. CIRURGICAS LTDA
    Product Code
    FMI
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: ONE (1) SAMPLE WAS PROVIDED BY THE CUSTOMER FOR INVESTIGATION. THE RETURNED SAMPLE WAS VISUALLY EXAMINED AND IT WAS OBSERVED THAT THE SAMPLE WAS CLOGGED AS LIGHT WAS NOT ABLE TO PASS THROUGH THE SAMPLE. THE DHR REVIEWS DID NOT REVEAL ANY DEFECTS OR ISSUES REPORTED AND NO QUALITY NOTIFICATIONS WERE ISSUED. FOREIGN MATERIAL (FM) CAN BE INTRODUCED TO THE FLUID PATH DURING THE MANUFACTURING PROCESS WHICH COULD CAUSE THE NEEDLE TO BECOME CLOGGED. ALL PRODUCT IS AUTOMATICALLY CHECKED FOR CLOGGED NEEDLES DURING THE PRODUCTION PROCESS. BD ACKNOWLEDGES THAT THE RETURNED NEEDLES WERE CLOGGED. AS THIS OCCURRENCE WOULD NOT EXCEED THE ACCEPTABLE QUALITY LEVEL (AQL) FOR THE BATCH NO CORRECTIVE OR PREVENTATIVE ACTIONS ARE PROPOSED IN THE SCOPE OF THIS COMPLAINT. 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 THAT AN UNSPECIFIED NUMBER OF NEEDLE PRECISIONGLIDE 30X1/2IN EXPERIENCED A CLOGGED/BLOCKED NEEDLE WHICH WAS NOTED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: I MADE THE PURCHASE OF 400 0.30X13MM (30GX1 / 2 ") NEEDLES, LOT 9112781, FAB 2019-05, IN ORDER TO PERFORM INVASIVE AESTHETIC PROCEDURES, BUT THE NEEDLES CAME IN LARGE PART WITH THE CLOGGED, MAKING IT IMPOSSIBLE TO USE.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF NEEDLE PRECISIONGLIDE 30 X 1/2 IN EXPERIENCED A CLOGGED/BLOCKED NEEDLE WHICH WAS NOTED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: I MADE THE PURCHASE OF 400 0.30 X 13 MM (30 G X 1 / 2 ") NEEDLES, LOT 9112781, FAB 2019-05, IN ORDER TO PERFORM INVASIVE AESTHETIC PROCEDURES, BUT THE NEEDLES CAME IN LARGE PART WITH THE CLOGGED, MAKING IT IMPOSSIBLE TO USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    638421 NEEDLE PRECISIONGLIDE 30X1/2IN NEEDLE FMI BECTON DICKINSON IND. CIRURGICAS LTDA 9112781

    Patients

    Seq Age Sex Outcome Treatment
    1 Other