BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENCAN

    MDR report key: 5664541 · Received May 18, 2016

    Report

    Report Number
    9610825-2016-00308
    Event Type
    Injury
    Date Received
    May 18, 2016
    Report Date
    April 22, 2015
    Manufacturer
    B. BRAUN MELSUNGEN AG
    Product Code
    MIA
    PMA / PMN Number
    K112515
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER E2011009. 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 USED (CONTAMINATED WITH BLOOD) PENCAN 27GX3 1/2" (88MM)-EU IN OPEN PACKAGING AND ONE PENCAN 27GX3 1/2" (88MM)-EU IN ORIGINAL PACKAGING. THE RECEIVED SAMPLES WERE TAKEN TO A VISUAL EXAMINATION. THE USED PENCAN CANNULA WAS BROKEN OFF APPROX. 46 MM AWAY FROM THE CANNULA HUB. THE STRUCTURE OF THE BREAK OF THE RAW CANNULA SHOWS THAT THE CANNULA WAS BENT BEFORE THE BREAK. IN ADDITION, THE OUTSIDE DIAMETER OF THE PENCAN CANNULAS WERE MEASURED ACCORDING TO DRAWING. NOMINAL-VALUE: 0.42 +0.01/-0 MM. ACTUAL-VALUES: USED SAMPLE= 0.42 MM; SAMPLE IN ORIGINAL PACKAGING= 0.42 MM. THE MEASURED VALUES (OUTSIDE DIAMETERS) OF THE PENCAN CANNULAS ARE IN ACCORDANCE WITH OUR SPECIFICATION. WITH REGARD TO THE USED SAMPLE WE ASSUME OF PROBLEM DURING THE APPLICATION AND CONSIDER THE COMPLAINT TO BE NOT JUSTIFIED. WE HAVE INFORMED OUR MANUFACTURER ACCORDINGLY. A REVIEW OF THE BATCH AND MANUFACTURING RECORDS REVEALED NO ABNORMALITIES OR NONCONFORMITIES.

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER E2011009. 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). THE DEVICE IS CURRENTLY SHIPPING FROM FRANCE TO OUR BBM LABORATORY IN GERMANY FOR INVESTIGATION. A FOLLOW-UP REPORT WILL BE PROVIDED WHEN THE INSPECTION RESULTS ARE AVAILABLE.

    Description of Event or Problem · 0

    AS REPORTED BY THE USER FACILITY ((B)(4)): THE NEEDLE BROKE DURING SPINAL ANESTHESIA. THE NEEDLE TIP HAS REMAINED AT THE INSIDE OF THE PATIENT'S SPINE WHEN REMOVAL OF THE NEEDLE. THE PATIENT WAS HOSPITALIZED TO RETRIEVE THE FOREIGN BODY. THE INTERVENTION LASTED 2 HOURS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    319591 PENCAN SPINAL NEEDLE MIA B. BRAUN MELSUNGEN AG N/A 14N09H8B23

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| O| R