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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PAJUNK GMBH MEDIZINTECHNOLOGIE EPILONG SOFT KIT FOR CONTINUOUS EPIDURAL ANAESTHESIA

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PAJUNK GMBH MEDIZINTECHNOLOGIE EPILONG SOFT KIT FOR CONTINUOUS EPIDURAL ANAESTHESIA Back to Search Results
Model Number 0431157-51
Device Problem Retraction Problem (1536)
Patient Problem Awareness during Anaesthesia (1707)
Event Date 04/01/2016
Event Type  malfunction  
Manufacturer Narrative
Event took place in (b)(6) and has been reported through (b)(4) distribution subsidiary pajunk medical produkte (b)(4). Currently the data is poor and the device has not been sent back/ analysed. As soon as further data will be available a follow up report will be sent into the agency.
 
Event Description
(b)(4). Tentative summarizing translation of initial reporter's narrative: ülacement of catheter for continuous epidural anaesthesia, unable to draw back needle over catheter; stylet got hooked in inner coil. Catheter had to be replaced, procedure re-initialized.
 
Manufacturer Narrative
With one of the devices involved an individual device failure can be confirmed. The second catheter has been stretched and ruptured due to handling-based complications. Based on risk assessment and clinical evaluation file is considered as closed.
 
Event Description
(b)(4). Tentative summarizing translation of initial reporter's narrative: placement of catheter for continuous epidural anaesthesia, unable to draw back needle over catheter; stylet got hooked in inner coil. Catheter had to be replaced, procedure re-initialized. Amendment: 2 catheter kits involved. Lot is unknown, packaging has been disposed.
 
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Brand NameEPILONG SOFT
Type of DeviceKIT FOR CONTINUOUS EPIDURAL ANAESTHESIA
Manufacturer (Section D)
PAJUNK GMBH MEDIZINTECHNOLOGIE
karl-hall-str. 1
geisingen, baden-wuerttemberg 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
regulatory & safety affairs
geisingen, baden-wuerttemberg 78187
GM   78187
7704929158
MDR Report Key5596965
MDR Text Key44180645
Report Number9611612-2016-00050
Device Sequence Number1
Product Code CAZ
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K060311
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/06/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/22/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number0431157-51
Device Catalogue Number0431157-51
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/20/2016
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/12/2016
Was Device Evaluated by Manufacturer? Yes
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: 04/22/2016 Patient Sequence Number: 1
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