BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPINOCAN®

    MDR report key: 17646474 · Received August 29, 2023

    Report

    Report Number
    9610825-2022-00557
    Event Type
    Injury
    Date Received
    August 29, 2023
    Report Date
    August 29, 2023
    Manufacturer
    B. BRAUN MELSUNGEN AG
    Product Code
    MIA
    UDI-DI
    04046964478673
    PMA / PMN Number
    K982805
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN INTERNAL REPORT NUMBER (B)(4). WE RECEIVED ONE USED SPINOCAN-KAN. KOMPL.D0.53/120 (25GX4.3/4") WITHOUT PACKAGING AND ONE SPINOCAN-KAN. KOMPL. D0.53/120 (25GX4.3/4") IN ORIGINAL PACKAGING. THE RECEIVED SAMPLES WERE TAKEN TO A VISUAL INSPECTION FOR DAMAGES ACCORDING TO THE SAP TEST PLAN AND TEST METHOD DAMAGES. THE USED CANNULA IS BROKEN OFF AND BEND. AT THE SAMPLE IN ORIGINAL PACKAGING, WE DETECTED NO DAMAGES AND NO MANUFACTURING FAULTS. IN ADDITION, THE OUTSIDE DIAMETER OF THE SPINOCAN CANNULAS WERE MEASURED ACCORDING TO DRAWING. NOMINAL-VALUE: 0.53 +0.01/-0 MM. ACTUAL-VALUE: 0.53 MM - 0.54 MM. THE MEASURED VALUE (OUTSIDE DIAMETERS) OF THE SPINOCAN CANNULAS ARE IN ACCORDANCE WITH THE SPECIFICATION. WITH REGARD TO THE BROKEN OFF AND BEND SAMPLE WE ASSUME OF A PROBLEM DURING THE APPLICATION PROCESS AND THEREFORE, WE CONSIDER THE COMPLAINT AS NOT CONFIRMED. NO ABNORMALITIES WERE FOUND IN THE MANUFACTURING RECORDS OF THE CONCERNED BATCHES.

    Additional Manufacturer Narrative · 0

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN INTERNAL REPORT NUMBER (B)(4). THE COMPLAINT IS STILL UNDER INVESTIGATION. A FOLLOW-UP REPORT WILL BE PROVIDED, AS SOON AS INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 0

    AS REPORTED BY THE USER FACILITY (TRANSLATION OF USER FACILITY INFORMATION BY BBM SALES ORGANIZATION IN SWEDEN; "NEEDLE BROKEN OFF." "ANESTHESIOLOGIST IS TO APPLY SPINAL ANESTHESIA TO A WOMAN IN LABOR. DURING THE PROCEDURE, A PINK IS USED RETRACTOR CANNULA TO PIERCE THE SKIN, THE SPINAL NEEDLE IS THEN INSERTED THROUGH THE PINK CANNULA (THE PINK THE CANNULA IS USED AS AN INTRODUCER). WHEN REVERSING THE SPINAL NEEDLE, IT IS PERCEIVED AS BEING STUCK. IT COMES OFF BUT WHEN IT COMES OUT OF THE PATIENT, ABOUT 6 CM OF THE DISTAL PART OF THE SPINAL NEEDLE IS MISSING. AFTER CONSULTATION WITH A SPINAL SURGEON, NO IMMEDIATE ACTION WAS TAKEN AND THE PATIENT WAS DELIVERED. AFTER DELIVERY, A PLAIN X-RAY WAS TAKEN. THE NEEDLE WAS SUPERFICIAL. THE SPINE SURGEON WAS ABLE TO REMOVE THE NEEDLE UNDER LOCAL ANAESTHETIC. WE HAVE TRIED TO REPLICATE THE RESULTS WITH INTERRUPTED SPINAL NEEDLE BY SIMULATING THE COURSE WITH A PINK RETRACTOR CANNULA AND A SPINAL NEEDLE WITHDRAWN THROUGH THE CANNULA. THIS HAS NOT, DESPITE REPEATED ATTEMPTS RESULTED IN A SPINAL NEEDLE OF THE SAME MAKE BREAKING OFF. HOWEVER, IT CANNOT BE RULED OUT THAT THE FAULTY ACTIVE USE WAS THE CAUSE OF THE INCIDENT."

    Description of Event or Problem · 0

    AS REPORTED BY THE USER FACILITY (TRANSLATION OF USER FACILITY INFORMATION BY BBM SALES ORGANIZATION IN SWEDEN; "NEEDLE BROKEN OFF." "ANESTHESIOLOGIST IS TO APPLY SPINAL ANESTHESIA TO A WOMAN IN LABOR. DURING THE PROCEDURE, A PINK IS USED RETRACTOR CANNULA TO PIERCE THE SKIN, THE SPINAL NEEDLE IS THEN INSERTED THROUGH THE PINK CANNULA (THE PINK THE CANNULA IS USED AS AN INTRODUCER). WHEN REVERSING THE SPINAL NEEDLE, IT IS PERCEIVED AS BEING STUCK. IT COMES OFF BUT WHEN IT COMES OUT OF THE PATIENT, ABOUT 6 CM OF THE DISTAL PART OF THE SPINAL NEEDLE IS MISSING. AFTER CONSULTATION WITH A SPINAL SURGEON, NO IMMEDIATE ACTION WAS TAKEN AND THE PATIENT WAS DELIVERED. AFTER DELIVERY, A PLAIN X-RAY WAS TAKEN. THE NEEDLE WAS SUPERFICIAL. THE SPINE SURGEON WAS ABLE TO REMOVE THE NEEDLE UNDER LOCAL ANAESTHETIC. WE HAVE TRIED TO REPLICATE THE RESULTS WITH INTERRUPTED SPINAL NEEDLE BY SIMULATING THE COURSE WITH A PINK RETRACTOR CANNULA AND A SPINAL NEEDLE WITHDRAWN THROUGH THE CANNULA. THIS HAS NOT, DESPITE REPEATED ATTEMPTS RESULTED IN A SPINAL NEEDLE OF THE SAME MAKE BREAKING OFF. HOWEVER, IT CANNOT BE RULED OUT THAT THE FAULTY ACTIVE USE WAS THE CAUSE OF THE INCIDENT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    729861 SPINOCAN® SPINAL NEEDLE MIA B. BRAUN MELSUNGEN AG 19F04A8701 04046964478673

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown