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U.S. Department of Health and Human Services

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

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PAJUNK GMBH MEDIZINTECHNOLOGIE KIT FOR EPIDURAL ANAESTHESIA CONTINUOUS EPIDURAL ANAESTHESIA KIT Back to Search Results
Model Number 001151-637
Device Problems Nonstandard Device (1420); Device Misassembled During Manufacturing /Shipping (2912)
Patient Problem Inadequate Pain Relief (2388)
Event Date 11/07/2017
Event Type  malfunction  
Manufacturer Narrative
Event took place in (b)(6) and has been reported through (b)(6) distribution subsidiary pajunk medical (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.
 
Event Description
(b)(4). Summarizing tentative translation from initial reporter´s narrative: unable to advance catheter over the ramp in the tip of the spinal needle.
 
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Brand NameKIT FOR EPIDURAL ANAESTHESIA
Type of DeviceCONTINUOUS EPIDURAL ANAESTHESIA KIT
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
geisingen, baden-wuerttemberg 78187
GM   78187
MDR Report Key7057553
MDR Text Key93572515
Report Number9611612-2017-00014
Device Sequence Number1
Product Code CAZ
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K082183
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Reporter Occupation
Type of Report Initial
Report Date 11/24/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/24/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number001151-637
Device Catalogue Number001151-637
Device Lot Number26217
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/14/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received11/07/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/01/2017
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: 11/24/2017 Patient Sequence Number: 1
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