BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENCAN

    MDR report key: 10704733 · Received October 20, 2020

    Report

    Report Number
    9610825-2020-00259
    Event Type
    Injury
    Date Received
    October 20, 2020
    Date of Event
    September 8, 2020
    Report Date
    October 20, 2020
    Manufacturer
    B. BRAUN MELSUNGEN AG
    Product Code
    BSP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN INTERNAL REPORT NUMBER (B)(4). WE RECEIVED A RAW CANNULA (WITH CANNULA TIP) OF AN USED PENCAN 25GX4" (103MM) M. FK-EU/AP/SA WITHOUT PACKAGING. VISUAL INSPECTION: THE RECEIVED RAW CANNULA WAS TAKEN TO A VISUAL INSPECTION FOR DAMAGES. THE USED PENCAN CANNULA IS BROKEN OFF AND BENT. THE CANNULA HUB WAS NOT HANDED OVER BY THE CUSTOMER. THE AREA OF THE BREAK FROM SHOWS THAT THE CANNULA WAS BENT BEFORE THE BREAK. PHYSICAL INSPECTION: AFTERWARDS THE LENGTH OF THE RAW CANNUAL WAS MEASURED ACCORDING TO THE DRAWING. NOMINAL: 103 MM +/- 1 MM, ACTUAL: 60 MM. IN ADDITION, THE OUTSIDE DIAMETER OF THE PENCAN CANNULA (SEVERAL AREAS) WAS MEASURED ACCORDING TO DRAWING. NOMINAL-VALUE: 0.53 MM +0.01/-0 MM, ACTUAL-VALUE: 0.54 MM, THE MEASURED VALUE (OUTSIDE DIAMETERS) OF THE PENCAN CANNULA IS IN ACCORDANCE WITH THE SPECIFICATION. SUMMARY AND ASSESSMENT: BECAUSE THE MEASURED VALUE IS WITHIN THE SPECIFICATION AND THE SAMPLE WAS ALREADY USED, WE ASSUME OF A PROBLEM DURING THE APPLICATION PROCESS. BASED ON THE CONDUCTED INVESTIGATIONS THE TESTED SAMPLE IS WITHIN THE SPECIFICATION. THEREFORE THE COMPLAINT IS CONSIDERED AS NOT CONFIRMED. RETAINED SAMPLE INVESTIGATION: FUNCTIONAL TEST: NO ABNORMALITY WAS IDENTIFIED. BENDING STIFFNESS TEST WAS CONDUCTED ON THE RETENTION SAMPLE OF CANNULA TUBES. INSPECTED ITEM: PENCAN 25GX4 W.INTRO.-EU/AP MATERIAL NO.: 4502116-13XX, BATCH NO.: 18K17H8B06. RESULT: 0.359 MM, SPECIFICATION: MAX 0.43 MM (THIN WALLED TUBING), SPAN: 10.0 MM,. TEST LOAD: 7.0 N JUDGEMENT: PASSED. REVIEW MANUFACTURING RECORDS: WE INVESTIGATED OUR MANUFACTURING RECORDS OF THE CONCERNED BATCHES NOT ANY ABNORMALITY WAS FOUND. JUSTIFICATION: THIS COMPLAINT WAS NOT CONFIRMED. NOTE: THIS REPORT IS BEING FILED FOR AN ITEM NUMBER THAT IS NOT SOLD IN THE UNITED STATES, HOWEVER THIS ITEM OR SIMILAR ITEMS ARE SOLD IN THE UNITED SATES BY B. BRAUN MEDICAL, INC.

    Description of Event or Problem · 1

    AS REPORTED BY THE USER FACILITY (TRANSLATION OF USER FACILITY INFORMATION BY (B)(4) ORGANIZATION IN (B)(4)): NEEDLE BROKEN OFF DURING USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1168955 PENCAN NEEDLE, CONDUCTION, ANESTH BSP B. BRAUN MELSUNGEN AG 18K17H8B06

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention