BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENCAN®

    MDR report key: 8727814 · Received June 24, 2019

    Report

    Report Number
    9610825-2019-00232
    Event Type
    Injury
    Date Received
    June 24, 2019
    Date of Event
    May 8, 2019
    Report Date
    June 24, 2019
    Manufacturer
    B. BRAUN MELSUNGEN AG
    Product Code
    BSP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER E2016018 B. BRAUN MEDICAL, INC. (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF B. BRAUN MELSUNGEN AG (MANUFACTURER). THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MELSUNGEN AG INTERNAL REPORT #(B)(4). WE RECEIVED 1 USED PENCAN 27GX3 1/2" (88MM) M. FK-EU/AP/SA IN OPEN PACKAGING. THE RECEIVED SAMPLE WAS TAKEN TO A VISUAL INSPECTION. THE RAW CANNULA WAS BROKEN OFF DIRECTLY IN THE AREA OF THE CANNULA HOUSING AT THE SAMPLE. THE BROKEN OFF RAW CANNULA IS INSIDE THE INTRODUCER NEEDLE. THE STRUCTURE OF THE BREAK SHOWS THAT THE CANNULA WAS BENT DURING USE. MANUFACTURING FAULTS WERE NOT DETECTED AT THE PENCAN CANNULA. AFTERWARDS THE OUTSIDE DIAMETER OF THE PENCAN CANNULA WAS MEASURED ACCORDING TO DRAWING. NOMINAL-VALUE: 0.42 +0.01/-0 MM. ACTUAL-VALUE OF THE USED SAMPLE: 0.42 MM. THE MEASURED VALUE (OUTSIDE DIAMETER) OF THE PENCAN CANNULA IS WITHIN OUR SPECIFICATION. WE ASSUME OF A PROBLEM DURING THE APPLICATION AND CONSIDER THE COMPLAINT AS NOT CONFIRMED. NOTE: THIS REPORT IS BEING FILED FOR AN ITEM NUMBER THAT IS NOT SOLD IN THE UNITED STATES, HOWEVER SIMILAR ITEMS ARE SOLD IN THE UNITED STATES BY B. BRAUN MEDICAL, INC.

    Description of Event or Problem · 0

    AS REPORTED BY THE USER FACILITY (TRANSLATION OF USER FACILITY INFORMATION BY BBM SALES ORGANIZATION IN POLAND): DURING PERFORM OF SPINAL ANESTHESIA FOR ORTHOPEDIC PROCEDURE (THA) APPEARED PROBLEM WITH POSITIONING SPINAL NEEDLE IN SPINAL SPACE. ANESTHESIOLOGIST DECIDED TO WITHDRAW NEEDLE AND REPEAT PROCEDURE AGAIN. WHEN THE NEEDLE WAS WITHDRAWN, STATED NEEDLE WAS BROKEN. ABOUT 3 CM BROKEN NEEDLE REMAINS IN PATIENT SPINE. PERFORMED CT AND CONFIRMED BROKEN PART OF NEEDLE STAYED IN SPINE. PATIENT WAS TRANSPORTED FOR NEUROSURGERY WARD IN OTHER HOSPITAL, WHERE BROKEN PART OF NEEDLE WAS REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    520449 PENCAN® NEEDLE, CONDUCTION, ANESTH BSP B. BRAUN MELSUNGEN AG 18G20H8B05

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention