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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PAJUNK GMBH MEDIZINTECHNOLOGIE STIMULONG NANOLINE ANESTHESIA CONDUCTION KIT

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PAJUNK GMBH MEDIZINTECHNOLOGIE STIMULONG NANOLINE ANESTHESIA CONDUCTION KIT Back to Search Results
Model Number 531156-32C
Device Problems Break (1069); Detachment Of Device Component (1104)
Patient Problem Pain (1994)
Event Date 09/28/2017
Event Type  malfunction  
Event Description
Physician was placing a left infraclavicular catheter for relief of complex regional pain syndrome. The physician was unable to elicit nerve stimulation with the catheter that had been placed. As the catheter was being withdrawn a 7 cm distal section broke off. A new catheter was placed without incident or harm to the patient.
 
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Brand NameSTIMULONG NANOLINE
Type of DeviceANESTHESIA CONDUCTION KIT
Manufacturer (Section D)
PAJUNK GMBH MEDIZINTECHNOLOGIE
6611 bay circle, suite 140
norcross , ga 30071 GA 30071
MDR Report Key6957507
MDR Text Key89591730
Report Number6957507
Device Sequence Number1
Product Code CAZ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation
Type of Report Initial
Report Date 10/09/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/18/2017
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/30/2020
Device Model Number531156-32C
Device Catalogue Number531156-32C
Device Lot Number1137
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA10/09/2017
Device Age2 YR
Event Location Hospital
Date Report to Manufacturer10/09/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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