BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PRECISIONGLIDE¿ NEEDLE

    MDR report key: 16109619 · Received January 5, 2023

    Report

    Report Number
    3003916417-2022-00322
    Event Type
    Malfunction
    Date Received
    January 5, 2023
    Date of Event
    December 16, 2022
    Report Date
    January 30, 2023
    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
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6. INVESTIGATION SUMMARY: NO SAMPLE OR PHOTO RECEIVED FOR INVESTIGATION. A DEVICE HISTORY RECORD REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION OF THE PROVIDED LOT NUMBER THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. LOT NUMBER REPORTED (6222460) WAS EXPIRED IN AUGUST 2021, HOWEVER RETENTION SAMPLES FROM THE SAME LOT WERE EVALUATED, NO DEFECTS OR ISSUES OBSERVED. RUPTURE FORCE TEST WERE PERFORMED ON THE NEEDLES, RESULTS WERE WITHIN THE SPECIFICATIONS. BD ALSO PERFORMED VISUAL INSPECTION ON THE RETENTION SAMPLES TO CHECK FOR MISSING OR LOW RESIN AND IT WAS NOT OBSERVED. BASED ON THE QUALITY TEAM'S INVESTIGATION, A ROOT CAUSE RELATED TO OUR MANUFACTURING PROCESS CANNOT BE IDENTIFIED AT THIS TIME.

    Additional Manufacturer Narrative · 0

    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 · 0

    IT WAS REPORTED THAT THE BD PRECISIONGLIDE¿ NEEDLE PULLED OUT OF THE HUB AFTER APPLYING THE PNEUMOCOCCAL 10-VALENT VACCINE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM PORTUGUESE: "THE NURSING TECHNICIAN, WHEN FINISHING APPLYING THE PNEUMOCOCCAL 10-VALENT VACCINE, OBSERVED THAT THE ROD WAS NOT CONNECTED WITH THE NEEDLE BARREL, STILL WITH HER HAND ON THE CHILD'S THIGH, NOTICED THAT A SMALL PORTION OF THE ROD WAS STILL EXPOSED, THUS, HE WAS ABLE TO PULL IT OFF WITHOUT FURTHER DAMAGE TO THE PATIENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD PRECISIONGLIDE¿ NEEDLE PULLED OUT OF THE HUB AFTER APPLYING THE PNEUMOCOCCAL 10-VALENT VACCINE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM PORTUGUESE: "THE NURSING TECHNICIAN, WHEN FINISHING APPLYING THE PNEUMOCOCCAL 10-VALENT VACCINE, OBSERVED THAT THE ROD WAS NOT CONNECTED WITH THE NEEDLE BARREL, STILL WITH HER HAND ON THE CHILD'S THIGH, NOTICED THAT A SMALL PORTION OF THE ROD WAS STILL EXPOSED, THUS, HE WAS ABLE TO PULL IT OFF WITHOUT FURTHER DAMAGE TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    153150 BD PRECISIONGLIDE¿ NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON IND. CIRURGICAS LTDA 6222460

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown