BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEEDLE PRECISIONGLIDE 30X1/2IN

    MDR report key: 9282502 · Received November 5, 2019

    Report

    Report Number
    3003916417-2019-00558
    Event Type
    Malfunction
    Date Received
    November 5, 2019
    Date of Event
    October 14, 2019
    Report Date
    December 16, 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: FIVE SAMPLE WERE RECEIVED. A FUNCTIONAL TEST WAS PERFORMED CONNECTING THE NEEDLE ASSEMBLY TO A SYRINGE PREFILLED WITH DISTILLED WATER AND THEY ALL WORKED WITH NO ISSUES. A VISUAL INSPECTION WAS PERFORMED WITH A 30X MICROSCOPE THERE WAS NO DAMAGE NOTED. THE BEVELS AND ETCH WERE GOOD. NO DEFECTIVE GRIND OR HOOKS WERE OBSERVED. FAILURE MODE COULD NOT BE VERIFIED HOWEVER, FOR THE CLOGGED NEEDLES, 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. 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. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A NEEDLE BLOCK OCCURRED DURING USE WITH A NEEDLE PRECISIONGLIDE 30X1/2IN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "I USE NEEDLES FOR OZONE APPLICATION AND FOR AESTHETIC PURPOSES AND SOME COLLEAGUES ARE HAVING PROBLEMS WITH THE QUALITY OF 30X13 NEEDLES, SOME WITH INSUFFICIENT OR COMPLETELY BLOCKED FLOW AND MANY, MANY WITH CUT FAILURES TEARING THE SKIN. ADDITIONAL INFORMATION: THE LOTS REPORTED ARE 9133643 AND 9165868. THERE WAS NO DAMAGE TO THE PATIENT, BUT IT WAS NECESSARY TO MAKE A NEW APPLICATION. THE CUSTOMER INFORMED THAT KEEP WITH 5 UNITS OF THE PRODUCT."

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 9133643. MEDICAL DEVICE EXPIRATION DATE: 2024-04-30. DEVICE MANUFACTURE DATE: 2019-05-14. MEDICAL DEVICE LOT #: 9165868. MEDICAL DEVICE EXPIRATION DATE: 2024-06-30. DEVICE MANUFACTURE DATE: 2019-06-27. (B)(6). 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 A NEEDLE BLOCK OCCURRED DURING USE WITH A NEEDLE PRECISIONGLIDE 30X1/2IN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "I USE NEEDLES FOR OZONE APPLICATION AND FOR AESTHETIC PURPOSES AND SOME COLLEAGUES ARE HAVING PROBLEMS WITH THE QUALITY OF 30X13 NEEDLES, SOME WITH INSUFFICIENT OR COMPLETELY BLOCKED FLOW AND MANY, MANY WITH CUT FAILURES TEARING THE SKIN.ADDITIONAL INFORMATION: THE LOTS REPORTED ARE 9133643 AND 9165868. THERE WAS NO DAMAGE TO THE PATIENT, BUT IT WAS NECESSARY TO MAKE A NEW APPLICATION. THE CUSTOMER INFORMED THAT KEEP WITH 5 UNITS OF THE PRODUCT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1070967 NEEDLE PRECISIONGLIDE 30X1/2IN NEEDLE FMI BECTON DICKINSON IND. CIRURGICAS LTDA SEE H.10

    Patients

    Seq Age Sex Outcome Treatment
    1 Other