BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEEDLE PRECISIONGLIDE 18X1-1/2IN

    MDR report key: 19912230 · Received August 5, 2024

    Report

    Report Number
    3003916417-2024-00188
    Event Type
    Malfunction
    Date Received
    August 5, 2024
    Date of Event
    July 17, 2024
    Report Date
    October 29, 2024
    Manufacturer
    BECTON DICKINSON IND. CIRURGICAS LTDA
    Product Code
    FMI
    UDI-DI
    50000078909736
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    (B)(4) SAMPLES AND PHOTOS RECEIVED BY OUR QUALITY TEAM FOR INVESTIGATION. THROUGH VISUAL INSPECTION, SILICONE ON THE HUB, WHITE EPOXY ON THE HUB, AND CRACKED NEEDLE HUB WERE CONFIRMED. NO OTHER DEFECTS OR ISSUES OBSERVED. YELLOW AND WHITE FOREIGN MATTER ARE IDENTIFIED AS EPOXY. EPOXY IS AN ADHESIVE USED TO JOIN THE CANNULA AND HUB. THE SILICONE EMPLOYED IN THIS PRODUCT IS A MEDICAL GRADE SILICONE AUTHORIZED FOR PRODUCT USE. FURTHERMORE, 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. BASED ON THE TEAMS INVESTIGATION, POSSIBLE ROOT CAUSE FOR SILICONE IS ASSOCIATED WITH FAILURE TO CLEAN THE SILICONE SYSTEM. POSSIBLE ROOT CAUSE FOR EPOXY IS RESIN APPLICATION. POSSIBLE ROOT CAUSE FOR CRACKED HUB IS ASSOCIATED WITH A JAMMING DURING ASSEMBLY PROCESS. BASED ON THE INVESTIGATION RESULTS, NO MANUFACTURING RELATED DEFECTS COULD BE IDENTIFIED FOR PACKAGING ISSUE AND THEREFORE, A CAUSE FOR THE REPORTED INCIDENT COULD NOT BE DETERMINED. FINAL PRODUCTS IN THIS MANUFACTURING LINE, FOR THIS REFERENCE ARE SAMPLED AND THEY ARE SUBJECTED TO VISUAL AND FUNCTIONAL INSPECTIONS DURING THE DIFFERENT MANUFACTURING SUB-PROCESSES ACCORDING TO PROCEDURES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD NEEDLE PRECISION GLIDE 18X1-1/2IN NEEDLE HUB HOLE / CRACKED / DAMAGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER TRANSLATED FROM PORTUGUESE TO ENGLISH: PROBE 1.20X40MM (18GX1 1/2'') LOT: 2243430 QUANTITY: 11 REASON: 1 BROKEN CANNON, 2 EXTENSION IN THE PROTECTIVE COVER PERFORATING THE PACKAGING, 3 FOREIGN BODIES (BOTH IN THE CANNON), 4 YELLOWING OF THE GLUE FROM THE WELDING OF THE PROBE WITH THE CANNON, 1 OVERFLOW OF WELDING GLUE IN THE CANNON. ADDITIONAL INFORMATION PROVIDED: DATE OF THE EVENT? SEGREGATED DAILY DURING THE MONTHS OF MAY TO JULY/2024 TO COLLECT SAMPLES: PLEASE INFORM: ORGANIZATION NAME: ESSENTIAL DRUGS AND NUTRITION CNPJ NUMBER: (B)(4). ICMS TAXPAYER (YES/NO): YES. PRODUCT PURCHASE INVOICE NUMBER: (B)(4) (PURCHASE VIA SURGICAL MAFRA) NF: (B)(4). (PURCHASE VIA SURGICAL SANTA CRUZ) (B)(4). (PURCHASE VIA SURGICAL SANTA CRUZ) NF: (B)(4). (PURCHASE VIA SURGICAL SANTA CRUZ) COMPLETE ADDRESS (STREET, ZIP CODE, NEIGHBORHOOD, CITY AND STATE); (B)(6). HOW MANY UNITS ARE AVAILABLE FOR COLLECTION? ALL UNITS NOTIFIED (B)(4) UNITS) IS THE SAMPLE CONTAMINATED? IF SO, PROVIDE THE SUBSTANCE. NO.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1844158 BD NEEDLE PRECISIONGLIDE 18X1-1/2IN NEEDLE FMI BECTON DICKINSON IND. CIRURGICAS LTDA 2243430 50000078909736

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown