BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD WHITACRE¿ SPINAL NEEDLE

    MDR report key: 16091562 · Received January 3, 2023

    Report

    Report Number
    2618282-2022-00102
    Event Type
    Injury
    Date Received
    January 3, 2023
    Date of Event
    December 14, 2022
    Report Date
    January 12, 2023
    Manufacturer
    BD CARIBE LTD.
    Product Code
    BSP
    UDI-DI
    00382904051389
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.

    Additional Manufacturer Narrative · 0

    AFTER FURTHER EVALUATION OF THE COMPLAINT, IT HAS BEEN DETERMINED THAT THE MDR 2618282-2022-00102 IS A DUPLICATE OF 2618282-2022-00095 THIS SUPPLEMENTAL IS TO CANCEL MDR 2618282-2022-00102.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD WHITACRE¿ SPINAL NEEDLE WAS FOUND "SHEARED OFF" WHEN REMOVING IT FROM THE EPIDURAL LIGAMENT. AS A RESULT, THE PATIENT'S CARDIAC SURGERY WAS POSTPONED, AND GENERAL ANESTHESIA WAS NEEDED TO EXTRACT THE BROKEN NEEDLE PIECE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "ATTEMPTED SPINAL PROCEDURE WITH 27G WHITACRE. THE NEEDLE WAS PASSED THROUGH THE 20G INTRODUCER AND ADVANCED INTO THE EPIDURAL LIGAMENT. NO CSF ENDPOINT WAS OBTAINED. THE INTRODUCER WAS REPLACED AND SPINAL NEEDLE ADVANCED TO THE HUB AND THERE STILL WAS NO CSF. THE NEEDLE WAS THEN WITHDRAWN. AFTER WITHDRAWING THE NEEDLE WAS FOUND TO BE SHEARED OFF. THE PATIENT'S CARDIAC SURGERY WAS POSTPONED. THE PATIENT REQUIRED GENERAL ANESTHESIA FOR EXTRACTION OF THE NEEDLE. THE PATIENT LATER HAD CARDIAC SURGERY. THERE WERE NO LONG TERM ADVERSE PATIENT IMPACT. BECTON DICKINSON CANADA INC YES / OUI CANADIAN HOSPITAL SPECIALTIES LTD (B)(6) 2022, PENDING ASSIGNMENT NO / NON A0401 - BREAK / BRIS; E2403 - NO CLINICAL SIGNS SYMPTOMS OR CONDITIONS / AUCUN SIGNE, SYMPTÔME OU CONDITION CLINIQUES; F19 - SURGICAL INTERVENTION / INTERVENTION CHIRURGICALE; F1909 - SURGICAL PROCEDURE DELAYED / PROCÉDURE CHIRURGICALE RETARDÉE

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD WHITACRE¿ SPINAL NEEDLE WAS FOUND "SHEARED OFF" WHEN REMOVING IT FROM THE EPIDURAL LIGAMENT. AS A RESULT, THE PATIENT'S CARDIAC SURGERY WAS POSTPONED, AND GENERAL ANESTHESIA WAS NEEDED TO EXTRACT THE BROKEN NEEDLE PIECE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "ATTEMPTED SPINAL PROCEDURE WITH 27G WHITACRE. THE NEEDLE WAS PASSED THROUGH THE 20G INTRODUCER AND ADVANCED INTO THE EPIDURAL LIGAMENT. NO CSF ENDPOINT WAS OBTAINED. THE INTRODUCER WAS REPLACED AND SPINAL NEEDLE ADVANCED TO THE HUB AND THERE STILL WAS NO CSF. THE NEEDLE WAS THEN WITHDRAWN. AFTER WITHDRAWING THE NEEDLE WAS FOUND TO BE SHEARED OFF. THE PATIENT'S CARDIAC SURGERY WAS POSTPONED. THE PATIENT REQUIRED GENERAL ANESTHESIA FOR EXTRACTION OF THE NEEDLE. THE PATIENT LATER HAD CARDIAC SURGERY. THERE WERE NO LONG TERM ADVERSE PATIENT IMPACT. BECTON DICKINSON CANADA INC YES / (B)(6) HOSPITAL SPECIALTIES LTD (B)(6) 2022; PENDING ASSIGNMENT NO / NON A0401 - BREAK / BRIS; E2403 - NO CLINICAL SIGNS SYMPTOMS OR CONDITIONS / AUCUN SIGNE, SYMPTÔME OU CONDITION CLINIQUES; F19 - SURGICAL INTERVENTION / INTERVENTION CHIRURGICALE; F1909 - SURGICAL PROCEDURE DELAYED / PROCÉDURE CHIRURGICALE RETARDÉE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    502133 BD WHITACRE¿ SPINAL NEEDLE ANESTHESIA CONDUCTION NEEDLE BSP BD CARIBE LTD. UNKNOWN 00382904051389

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention