BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENCAN

    MDR report key: 4740329 · Received April 28, 2015

    Report

    Report Number
    9610825-2015-00142
    Event Type
    Injury
    Date Received
    April 28, 2015
    Date of Event
    March 25, 2015
    Report Date
    April 1, 2015
    Manufacturer
    B. BRAUN MELSUNGEN AG
    Product Code
    BSP
    PMA / PMN Number
    K112515
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). WE RECEIVED ONE USED PENCAN 27GX3 1/2" (88MM) M. FK-EU/AP/SA WITHOUT PACKAGING. FURTHERMORE WE RECEIVED A CD WITH CT - PICTURES. THE RECEIVED SAMPLE WAS CHECKED VISUALLY. THE PENCAN CANNULA WAS BROKEN OFF APPROX. 57 MM AWAY FROM THE CANNULA HUB. IN 'AS-RECEIVED' CONDITION THE PENCAN CANNULA WAS STILL INSERTED INTO THE INTRODUCER NEEDLE. THE BROKEN OFF PART WITH THE CANNULA TIP WAS NOT HANDED OVER BY THE CUSTOMER. THE STRUCTURE OF THE BREAK SHOWS THAT THE CANNULA WAS BENT BEFORE IT BROKE.. PRE-DAMAGES OR MANUFACTURING FAULTS WERE NOT DETECTED AT THE CANNULA. IT IS LIKELY THAT PROBLEMS OCCURED DURING THE APPLICATION PROCESS AND CONSIDER THE COMPLAINT AS NOT JUSTIFIED. WE HAVE INFORMED OUR MANUFACTURER ACCORDINGLY. TEST RESULT OF OUR RETENTION SAMPLE: 1. VISUAL INSPECTION: ANY ABNORMALITY WERE NOT FOUND. 2. STIFFNESS TEST RESULT: RESULT: 0.29MM. THEY WERE WITHIN THE SPECIFICATION. (SPECIFICATION: MAXIMUM DEFLECTION 0.65MM).

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE IS CURRENTLY SHIPPING FROM (B)(6) TO (B)(4) FOR INVESTIGATION. A FOLLOW-UP REPORT WILL BE PROVIDED WHEN THE INSPECTION RESULTS BECOME AVAILABLE. WE HAVE INFORMED OUR MANUFACTURER ACCORDINGLY. REVIEWED THE DEVICE HISTORY RECORDS. ANY ABNORMALITY WAS NOT FOUND. THE RESULT OF STIFFNESS WAS WITHIN SPECIFICATION. (B)(4).

    Description of Event or Problem · 1

    AS REPORTED BY THE USER FACILITY ((B)(4)): LUMBAR PUNCTURE PERFORMED WITH ATRAUMATIC NEEDLE, NEEDLE INSERTION WITHOUT ANY DIFFICULTY, FAILURE OF THE PUNCTURE, DECISION TO WITHDRAW THE NEEDLE. DURING THE WITHDRAWAL, THERE IS A NEEDLE BENT AND BROKEN AT THE END WITH A PIECE REMAINED IN THE BODY OF THE PATIENT, OUTSIDE THE SPINAL CANAL. SURGICAL RESECTION PERFORMED ON (B)(6) 2015 URGENTLY BY THE NEUROSURGEON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    278957 PENCAN SPINAL NEEDLE BSP B. BRAUN MELSUNGEN AG NA 14K17H8B61

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK