• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

PAJUNK GMBH MEDIZINTECHNOLOGIE EPILONG SOFT EPIDURAL ANAESTHESIA KIT Back to Search Results
Model Number 0431157-51
Device Problems Retraction Problem (1536); Material Too Rigid or Stiff (1544)
Patient Problem No Information (3190)
Event Date 01/18/2016
Event Type  malfunction  
Manufacturer Narrative
Information on incident and device is poor at this time. Follow up will be sent as soon as further details become available. Not yet returned.
 
Event Description
(b)(4). Users narrative: unable to retract needle over the catheter. Stylet [of catheter] to rigid.
 
Manufacturer Narrative
Event took place in (b)(6). File is considered as closed.
 
Event Description
(b)(4). Users narrative: unable to retract needle over the catheter. Stylet [of catheter?] to rigid. Happened with 2 kits.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameEPILONG SOFT
Type of DeviceEPIDURAL 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
regulatory & safety affairs
geisingen, baden-wuerttemberg 78187
GM   78187
7704929158
MDR Report Key5446635
MDR Text Key39100258
Report Number9611612-2016-00016
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 06/14/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/19/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/01/2020
Device Model Number0431157-51
Device Catalogue Number0431157-51
Device Lot Number1123
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/27/2016
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/26/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/01/2015
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: 02/19/2016 Patient Sequence Number: 1
-
-