BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEEDLE PRECISIONGLIDE 16X1-1/2IN

    MDR report key: 19889169 · Received August 1, 2024

    Report

    Report Number
    3003916417-2024-00185
    Event Type
    Malfunction
    Date Received
    August 1, 2024
    Date of Event
    July 17, 2024
    Report Date
    October 15, 2024
    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
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B.3. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    SEVEN SAMPLES RECEIVED BY OUR QUALITY TEAM FOR INVESTIGATION. THROUGH VISUAL INSPECTION, DIRT ON THE SHIELD, DAMAGED SHIELD, EPOXY ON THE NEEDLE, AND LINT ON THE SHIELD ARE OBSERVED. EPOXY IS AN ADHESIVE USED TO JOIN THE CANNULA AND HUB. NO FOREIGN MATTER OBSERVED ON THE HUB, ADDITIONALLY, NO DEFECTS OR ISSUES OBSERVED ON THE PACKAGING OF THE PRODUCT. THERE ARE NO PUNCTURES OR HOLES. FUNCTIONAL TESTING WAS PERFORMED, NO CONTAMINATION WERE FOUND INSIDE THE PACKAGING. RETENTION SAMPLES FROM THE SAME LOT WERE EVALUATED, NO DEFECTS OR ISSUES OBSERVED. POSSIBLE ROOT CAUSE FOR DAMAGED SHIELD IS ASSOCIATED WITH PROTECTOR ENTANGLEMENT IN THE ASSEMBLY LINE BECOMING MISALIGNED CAUSING THE INCIDENT. LINT ON PROTECTOR IS ASSOCIATED WITH PLASTIC RESIDUE INSIDE THE CAVITY OF THE INJECTION POINT. NEW MOLDING REPLACEMENT WILL BE IMPLEMENTED. EPOXY AND DIRT ON THE SHIELD ARE ASSOCIATED WITH RESIN APPLICATION. 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 PRECISIONGLIDE 16X1-1/2IN HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER TRANSLATED FROM PORTUGUESE TO ENGLISH: PROBE 1.60X40MM (16GX1 1/2''). QUANTITY: (B)(4). LOT: 2243422/ REASON: 1 UNIT WITH A GELATINOUS FOREIGN BODY ON THE INSIDE OF THE PROTECTIVE CAP, 1 CRACKED PROTECTIVE CAP, 1 EXTENSION OF THE PROTECTIVE CAP PIERCING THE PLASTIC PACKAGING, 1 FOREIGN BODY IN THE BARREL, 1 FOREIGN BODY IN THE PROBE BODY, 2 BARRELS LEAKING GLUE FROM THE WELDS. 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: 20.511.326/0001-90. ICMS TAXPAYER (YES/NO): YES. PRODUCT PURCHASE INVOICE NUMBER: NF: (B)(4) (PURCHASE VIA SURGICAL MAFRA) NF: (B)(4) (PURCHASE VIA SURGICAL SANTA CRUZ) NF: (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) - PR. 85.802-030. SECTOR/DEPARTMENT: STOCK. CONTACT (NAME AND TELEPHONE) (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
    885979 BD NEEDLE PRECISIONGLIDE 16X1-1/2IN NEEDLE FMI BECTON DICKINSON IND. CIRURGICAS LTDA 2243422

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown