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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PAJUNK GMBH MEDIZINTECHNOLOGIE EPILONG TUOHY CONTINUOUS EPIDURAL ANAESTHESIA CONDUCTION KIT

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PAJUNK GMBH MEDIZINTECHNOLOGIE EPILONG TUOHY CONTINUOUS EPIDURAL ANAESTHESIA CONDUCTION KIT Back to Search Results
Model Number 041151-604
Device Problems Fracture (1260); Device Handling Problem (3265)
Patient Problem Foreign Body In Patient (2687)
Event Date 08/15/2014
Event Type  Injury  
Manufacturer Narrative
Event took place in (b)(6) and has been reported through (b)(4). Based on risk assessment and clinical evaluation file is considered as closed. As soon as further significant data will be available, a follow up report will be sent in to the agency. We consider this file as closed.
 
Event Description
(b)(4). Event took place 3 years ago in (b)(6) and has been reported now by hospital/ patient´s advocate. On (b)(6) 2014 "h l. 00 am", the anesthetist inserted a peridural catheter for labor analgesia on the patient. Positioning was easy and according to usual guidelines. At testing the dose of 2% lidocaine, the anesthetist could not inject the anesthetic; in the hypothesis that there may be obstruction at the filter level,she replaced it, but without any benefit. So she hypothesized it could be the obstruction of the catheter due to malposition (kneeling, loop), so she retracted and then removed it completely. At extraction, she found that the catheter was sliced about 6-7 cm from the tip, probably by the tuohy cannula tip.
 
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Brand NameEPILONG TUOHY
Type of DeviceCONTINUOUS EPIDURAL ANAESTHESIA CONDUCTION 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, 78187
GM 78187
Manufacturer Contact
christian quass
karl-hall-str. 1
geisingen, 78187
GM   78187
MDR Report Key6874994
MDR Text Key86558727
Report Number9611612-2017-00008
Device Sequence Number1
Product Code CAZ
Combination Product (y/n)N
Reporter Country CodeIT
PMA/PMN Number
K060311
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 09/19/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/19/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number041151-604
Device Catalogue Number041151-604
Device Lot NumberUNKNOWN
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 Received09/15/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 09/19/2017 Patient Sequence Number: 1
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