BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENCAN

    MDR report key: 6673491 · Received June 28, 2017

    Report

    Report Number
    9610825-2017-00127
    Event Type
    Malfunction
    Date Received
    June 28, 2017
    Date of Event
    May 23, 2017
    Report Date
    June 6, 2017
    Manufacturer
    B. BRAUN MELSUNGEN AG
    Product Code
    MIA
    UDI-DI
    04046964180941
    PMA / PMN Number
    K112515
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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 ONE PENCAN 27GX3 1/2" (88MM) M. FK-EU/AP/SA IN ORIGINAL PACKAGING. THE RETURNED SAMPLE WAS TAKEN TO A VISUAL INSPECTION. DAMAGES OR MANUFACTURING FAULTS ESPECIALLY AT THE RAW CANNULA WERE NOT DETECTED ON THE RETURNED SAMPLE. IN ADDITION, THE PENCAN CANNULA WAS TAKEN TO A MANUAL FUNCTION TEST IN COMBINATION WITH THE INTRODUCER NEEDLE. THE PENCAN CANNULA COULD BE PUSHED THROUGH THE INTRODUCER NEEDLE WITHOUT ANY RESISTANCE. WITHDRAWING WAS ALSO POSSIBLE WITHOUT ANY PROBLEMS. FUNCTION FAULTS WERE NOT DETECTED. FURTHERMORE, THE OUTSIDE DIAMETER OF THE PENCAN CANNULA WAS MEASURED ACCORDING TO THE DRAWING. NOMINAL: 0.42 +0.01/-0.00 MM (SEE ATTACHED DRAWING) ACTUAL: 0.42 MM THE MEASURED OUTSIDE DIAMETER OF THE PENCAN CANNULA IS WITHIN THE SPECIFICATION. IN ADDITION, THE PENCAN CANNULA WAS TAKEN TO A CANNULA STIFFNESS TEST ACCORDING TO THE TEST PLAN. NOMINAL: TEST FORCE = 5.5 N; BENDING MAX.= 0.55 MM ACTUAL: BENDING = 0.282 MM THE MEASURED VALUE IS WITHIN THE SPECIFICATION. THE RETURNED SAMPLE IS IN ACCORDANCE WITH THE SPECIFICATION. A REVIEW OF THE BATCH AND MANUFACTURING RECORDS REVEALED NO ABNORMALITIES OR NONCONFORMITIES.

    Description of Event or Problem · 0

    AS REPORTED BY THE USER FACILITY (TRANSLATION OF USER FACILITY INFORMATION BY BBM SALES ORGANIZATION IN GERMANY: CANNULA DETACHED INSIDE PATIENT

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    454289 PENCAN SPINAL NEEDLE MIA B. BRAUN MELSUNGEN AG N/A 16N23H8B21 04046964180941

    Patients

    Seq Age Sex Outcome Treatment
    1