BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STERICAN®

    MDR report key: 5501636 · Received March 15, 2016

    Report

    Report Number
    9610825-2016-00118
    Event Type
    Injury
    Date Received
    March 15, 2016
    Date of Event
    February 12, 2016
    Report Date
    February 19, 2016
    Manufacturer
    B. BRAUN MELSUNGEN AG
    Product Code
    FMI
    PMA / PMN Number
    K072247
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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). THE DEVICE IS CURRENTLY SHIPPING FROM UNITED KINGDOM TO BBM IN GERMANY FOR INVESTIGATION. A FOLLOW-UP REPORT WILL BE PROVIDED AFTER THE INSPECTION RESULTS ARE AVAILABLE. REVIEWED THE DEVICE HISTORY RECORD AND THERE WERE NO ABNORMALITY FOUND AT IN-PROCESS INSPECTION OR AT FINAL CONTROL INSPECTION

    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 STERICAN 0,50X40 25GX1 1/2 DENTAL 17/42 WITHOUT PACKAGE AND 26 STERICAN 0,50X40 25GX1 1/2 DENTAL 17/42 IN ORIGINAL PACKAGE. THE USED SAMPLE AND THE 26 ORIGINAL PACKED SAMPLES WERE TAKEN TO A VISUAL EXAMINATION. DAMAGES OR MANUFACTURING FAULTS WERE NOT DETECTED AT THE SAMPLES IN ORIGINAL PACKAGING. AT THE USED SAMPLE THE CANNULA WAS BROKEN OFF DIRECTLY AT THE CANNULA HUB. ONLY THE CANNULA HUB WAS HANDED OVER BY CUSTOMER. THE BROKEN OFF CANNULA WAS NOT HANDED OVER BY THE CUSTOMER. THE 26 ORIGINAL PACKED SAMPLES WERE TAKEN TO FUNCTION TEST. THE SAMPLES WERE INSERTED IN A RUBBER STOPPER OF A 100 ML "GLASS" BOTTLE. NO DAMAGES OR A BROKEN OFF CANNULA WE COULD DETECT. NOTE: IF WE APPLY A LARGE LATERAL FORCE, A BREAK OFF FROM THE CANNULA OUT OF THE CANNULA HOUSING IS POSSIBLE. THE DAMAGE AT THE USED SAMPLE RESULTED FROM A HIGH LATERAL FORCE, SO WE ASSUME A PROBLEM DURING THE APPLICATION PROCESS AND CONSIDER THE COMPLAINT AS NOT JUSTIFIED. WE RECEIVED THREE STERICAN 0,50X40 25GX1 1/2 DENTAL 17/42 IN ORIGINAL PACKAGE. THE SAMPLES WERE TAKEN TO A VISUAL EXAMINATION. DAMAGES OR MANUFACTURING FAULTS WERE NOT DETECTED AT THE SAMPLES IN ORIGINAL PACKAGING. FURTHER THE SAMPLES WERE TAKEN TO FUNCTION TEST. THE CANNULAS WERE INSERTED IN A RUBBER STOPPER OF A 100 ML "GLASS" BOTTLE. NO DAMAGES OR A BROKEN OFF CANNULA WE COULD DETECT. NOTE: IF WE APPLY A LARGE LATERAL FORCE, A BREAK OFF FROM THE CANNULA OUT OF THE CANNULA HOUSING IS POSSIBLE. WE CONSIDER THE COMPLAINT AS NOT "JUDGABLE".

    Description of Event or Problem · 0

    AS REPORTED BY THE USER FACILITY (TRANSLATION OF USER FACILITY INFORMATION BY BBM SALES ORGANIZATION IN (B)(4)): PATIENT ATTENDED RADIOLOGY FOR ULTRASOUND GUIDED DRAINAGE OF RIGHT PERIRENAL COLLECTION. THE CONSULTANT RADIOLOGIST INJECTED LIDOCAINE 2% TO ANAESTHETISE THE TISSUE PRIOR TO INSERTING THE DRAIN. WHEN HE WITHDREW THE NEEDLE HE REALIZED IT HAD SNAPPED OFF AT THE BASE AND WAS STILL IN THE PATIENT. RADIOLOGIST STATED THAT HE COULDN'T FEEL THE NEEDLE UNDER THE PALPATION THEREFORE COULDN'T ATTEMPT TO EXTRACT IT. HE SAID HE WAS PUZZLED AS HE HADN'T HIT THE BONE, THERE WAS NO RESISTANCE AND PATIENT'S SKIN WAS SOFT. DETAILS OF INJURY: RETAINED NEEDLE. ACTION TAKEN: NEEDLE HUB RETAINED WITH WRAPPER. LL AIR CALLED. LARGE LABEL ATTACHED TO THE PATIENT SKIN SITE TO BEWARE OF NEEDLE STILL WITHIN TISSUES. ABDO X RAY PERFOMED AND NEEDLE COULD BE VISUALISED ON XRAY. DOCUMENTED WITHIN RADIOLOGY NOTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    158720 STERICAN® STANDARD HYPODERMIC NEEDLES FMI B. BRAUN MELSUNGEN AG N/A 14K19G8842

    Patients

    Seq Age Sex Outcome Treatment
    1 Other