BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD WHITACRE NEEDLE

    MDR report key: 10273118 · Received July 14, 2020

    Report

    Report Number
    9610048-2020-00103
    Event Type
    Injury
    Date Received
    July 14, 2020
    Date of Event
    June 23, 2020
    Report Date
    July 23, 2020
    Manufacturer
    BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.
    Product Code
    BSP
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: A PHYSICAL SAMPLE WAS NOT AVAILABLE FOR INVESTIGATION BUT BD WAS PROVIDED WITH A PHOTO OF THE ISSUE FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED FOR THE REPORTED LOT, 9269745, AND NO QUALITY ISSUES WERE FOUND DURING PRODUCTION. OUR QUALITY ENGINEER REVIEWED THE PROVIDED PHOTO AND OBSERVED THAT THE NEEDLE WAS BROKEN. HOWEVER, IT WAS REPORTED THAT THE NEEDLE BROKE DURING USE. BASED OFF THE PROVIDED PHOTO THE ENGINEER WAS ABLE TO VERIFY THE REPORTED DEFECT. UNFORTUNATELY, A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE ADMINISTERING "HEAVY NEOCAINE", THE BD WHITACRE¿ NEEDLE BROKE OFF INSIDE THE PATIENT'S SUBCUTANEOUS TISSUE. SURGICAL INTERVENTION WAS REQUIRED TO REMOVE THE BROKEN NEEDLE TIP. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM PORTUGUESE TO ENGLISH: 'PRODUCT NEEDLE 27, DURING ANESTHESIA PROCEDURE IN PATIENT, THE NEEDLE BROKE. ITS DISTAL PART REMAINED INSIDE THE PATIENT'S SUBCUTANEOUS TISSUE, IT WAS REQUIRED A SURGICAL INTERVENTION TO REMOVE IT AS FOREIGN MATTER." "CORRECTION: THE NEEDLE THAT PRESENTED ISSUE DURING THE PROCEDURE WAS THE BD SPINAL 27GX3.5 OF BATCH 0031858, EXPIRATION DATE 01/31/2025 AND NOT THE PENCIL-TIP. MEDICATION THAT WAS BEING ADMINISTERED: HEAVY NEOCAINE."

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE ADMINISTERING "HEAVY NEOCAINE", THE BD WHITACRE¿ NEEDLE BROKE OFF INSIDE THE PATIENT'S SUBCUTANEOUS TISSUE. SURGICAL INTERVENTION WAS REQUIRED TO REMOVE THE BROKEN NEEDLE TIP. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM PORTUGUESE TO ENGLISH: 'PRODUCT NEEDLE 27, DURING ANESTHESIA PROCEDURE IN PATIENT, THE NEEDLE BROKE. ITS DISTAL PART REMAINED INSIDE THE PATIENT'S SUBCUTANEOUS TISSUE, IT WAS REQUIRED A SURGICAL INTERVENTION TO REMOVE IT AS FOREIGN MATTER." "CORRECTION: THE NEEDLE THAT PRESENTED ISSUE DURING THE PROCEDURE WAS THE BD SPINAL 27GX3.5 OF BATCH 0031858, EXPIRATION DATE 01/31/2025 AND NOT THE PENCIL-TIP. MEDICATION THAT WAS BEING ADMINISTERED: HEAVY NEOCAINE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    735770 BD WHITACRE NEEDLE ANESTHESIA CONDUCTION NEEDLE BSP BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA. 9269745

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention