BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WHITACRE

    MDR report key: 24193236 · Received January 27, 2026

    Report

    Report Number
    9610048-2026-00013
    Event Type
    Malfunction
    Date Received
    January 27, 2026
    Date of Event
    January 15, 2026
    Report Date
    February 23, 2026
    Manufacturer
    BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.
    Product Code
    BSP
    PMA / PMN Number
    K210978
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B3. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. H.3. A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION, A DEVICE EVALUATION, OR A DEVICE HISTORY REVIEW IS COMPLETED.

    Additional Manufacturer Narrative · 0

    A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR FINAL MATERIAL NUMBER 408394 AND THE POTENTIAL LOT NUMBERS PROVIDED 5177523, 5142575, AND 5022383. DURING THE MANUFACTURING PROCESS, TESTING IS PERFORMED TO ASSESS THE PACKAGE QUALITY, INCLUDING EVALUATING FOR DAMAGED CARTON AND SHELF, PRODUCT IN THE SEALING AREA, SEALING WRINKLE, CAVITY WRINKLE, SEAL WIDTH, FILM THICKNESS, DAMAGED OR TWISTED BLISTER, AND PERFORATION (IRREGULAR EDGES AND CUTS). BASED ON THE MANUFACTURING RECORD REVIEW, NO DISCREPANCIES OR NON-CONFORMANCE'S WERE FOUND THAT COULD HAVE CONTRIBUTED TO THE REPORTED INCIDENTS. AS SAMPLES WERE NOT AVAILABLE AT THIS TIME, A THOROUGH SAMPLE ANALYSIS COULD NOT BE PERFORMED. AT THIS TIME, A MANUFACTURING RELATED CAUSE COULD NOT BE DETERMINED FOR THE REPORTED INCIDENTS. THERE WERE NO PREVIOUS COMPLAINT REPORTS RECEIVED ON LOT NUMBERS 5177523, 5142575, AND 5022383 FOR DEFECTS RELATING TO PRIMARY PACKAGE INTEGRITY. AT THIS TIME, FURTHER ACTION HAS NOT BEEN DETERMINED NECESSARY. OUR QUALITY TEAM WILL CONTINUE TO CLOSELY MONITOR THE MANUFACTURING PROCESS FOR SIGNS OF THIS POTENTIAL DEFECT AND ANY EMERGING TRENDS.

    Description of Event or Problem · 0

    POOR QUALITY CASING: OFTEN FOUND TORN OR DAMAGED, WHICH RESULTS IN CONTAMINATION OF THE NEEDLE, MAKING IT UNUSABLE AND INCREASING THE RISK OF INFECTION. WASTE OF MATERIALS, WITH THE NEED FOR MULTIPLE NEEDLES IN THE SAME PATIENT, INCREASING OPERATING COSTS.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    250063 WHITACRE NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER) BSP BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown