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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PAJUNK GMBH MEDIZINTECHNOLOGIE STIMULONG NANOLINE CONTINUOUS PERIPHERAL NERVE BLOCK KIT

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PAJUNK GMBH MEDIZINTECHNOLOGIE STIMULONG NANOLINE CONTINUOUS PERIPHERAL NERVE BLOCK KIT Back to Search Results
Model Number 531156-32C
Device Problem Fracture (1260)
Patient Problem Foreign Body In Patient (2687)
Event Date 09/28/2017
Event Type  Injury  
Manufacturer Narrative
User facilities report number: (b)(4). Based on risk assessment and clinical evaluation file is considered as closed.
 
Event Description
(b)(4). Initial reporters narrative: dr. (b)(6) was performing a left infraclavicular catheter placement. According to the doctor, they could not get any stimulation. He said he usually only inserts the catheter a few centimeters past the tip of the needle. When they could not get a stimulation, the needle and catheter were pulled out together. This is when he said the catheter sheered and left a piece in the patient. The procedure was completed with a 2nd kit and broken piece was surgically removed 7 days later. Hospital would not release catheter being held in pathology but i was able to examine it and take pictures. The amount of catheter left in the patient (close to 7cm) is inconsistent with the doctor's description of the procedure. When dr. (b)(6) was unable to stimulate, rather than remove the catheter and needle together, the tuohy needle should have been removed first, leaving the catheter in place. At that time the catheter could then be removed safely. There is nothing i observed on the catheter or 50mm tuohy needle that indicated any flaws that could have contributed to the sheering of the catheter. Per the information at (b)(6) pathology lab: date of procedure: (b)(6) 2017. Date of removal of catheter piece: (b)(6) 2017. (b)(6). Catheter pieces reviewed and pictures taken on (b)(6) 2017.
 
Manufacturer Narrative
(b)(4).
 
Event Description
(b)(4). Dr. (b)(6) was performing a left infraclavicular catheter placement. According to the doctor, they could not get any stimulation. He said he usually only inserts the catheter a few centimeters past the tip of the needle. When they could not get a stimulation, the needle and catheter were pulled out together. This is when he said the catheter sheered and left a piece in the patient. The procedure was completed with a 2nd kit and broken piece was surgically removed 7 days later. Hospital would not release catheter being held in pathology but i was able to examine it and take pictures. The amount of catheter left in the patient (close to 7 cm) is inconsistent with the doctor's description of the procedure. When dr. (b)(6) was unable to stimulate, rather than remove the catheter and needle together, the tuohy needle should have been removed first, leaving the catheter in place. At that time the catheter could then be removed safely. There is nothing i observed on the catheter or 50 mm tuohy needle that indicated any flaws that could have contributed to the sheering of the catheter. Per the information at (b)(6) pathology lab: date of procedure: (b)(6) 2017. Date of removal of catheter piece: (b)(6) 2017 (b)(4). Catheter pieces reviewed and pictures taken on (b)(6) 2017.
 
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Brand NameSTIMULONG NANOLINE
Type of DeviceCONTINUOUS PERIPHERAL NERVE BLOCK KIT
Manufacturer (Section D)
PAJUNK GMBH MEDIZINTECHNOLOGIE
karl-hall-str. 1
geisingen, 78187
GM 78187
Manufacturer (Section G)
PAJUNK GMBH MEDIZINTECHNOLOGIE
karl-hall-str. 1
geisingen, baden-wuerttemberg 78187
GM 78187
Manufacturer Contact
christian quass
karl-hall-str. 1
geisingen, baden-wuerttemberg 78187
GM   78187
MDR Report Key7002740
MDR Text Key252948632
Report Number9611612-2017-00010
Device Sequence Number1
Product Code CAZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K053283
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,other
Reporter Occupation Risk Manager
Type of Report Initial,Followup
Report Date 11/24/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/06/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date11/01/2020
Device Model Number531156-32C
Device Catalogue Number531156-32C
Device Lot Number1137
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received10/24/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/01/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 11/06/2017 Patient Sequence Number: 1
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