• 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 PLEXOLONG NANOLINE KIT CONTINUOUS PERIPHERAL ANAESTHESIA CONDUCTION 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 PLEXOLONG NANOLINE KIT CONTINUOUS PERIPHERAL ANAESTHESIA CONDUCTION KIT Back to Search Results
Model Number 521156-31C
Device Problems Fracture (1260); Material Rupture (1546)
Patient Problem Foreign Body In Patient (2687)
Event Date 01/11/2018
Event Type  Injury  
Manufacturer Narrative
Event took place in (b)(6) and has been reported through (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 in to the agency.
 
Event Description
(b)(4). Summarizing tentative translation from initial reporter´s narrative: catheter rupture. A 150mm fragment remains with patient.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NamePLEXOLONG NANOLINE KIT
Type of DeviceCONTINUOUS PERIPHERAL ANAESTHESIA CONDUCTION 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 Key7246915
MDR Text Key99185298
Report Number9611612-2018-00013
Device Sequence Number1
Product Code CAZ
Combination Product (y/n)N
Reporter Country CodeIT
PMA/PMN Number
K053283
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/11/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/07/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number521156-31C
Device Catalogue Number521156-31C
Device Lot Number1207
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/05/2018
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received02/05/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/23/2017
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: 02/07/2018 Patient Sequence Number: 1
-
-