• 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 TUOHY ANAESTHESIA CONDUCTION KIT, CONTINUOUS, EPIDURAL

  • 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 TUOHY ANAESTHESIA CONDUCTION KIT, CONTINUOUS, EPIDURAL Back to Search Results
Model Number 0331152-51
Device Problems Nonstandard Device (1420); Product Quality Problem (1506); Device Misassembled During Manufacturing /Shipping (2912); No Flow (2991)
Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Event Date 12/28/2017
Event Type  malfunction  
Manufacturer Narrative
Based on risk management and clinical evaluation this incident is considered as closed. (b)(4).
 
Event Description
(b)(4). Summarizing translation from initial reporter´s narrative: the epidural catheter is lacking the distal central opening. No anaesthesia conduction. Catheter has to be removed/ replaced. Prologued initial anaesthesia procedure (approx. 15 minutes). No adverse outcome for the patient.
 
Manufacturer Narrative
Event took place in (b)(6) and has been reported through (b)(4) distribution subsidiary (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 translation from initial reporter´s narrative: the epidural catheter is lacking the distal central opening. No anaesthesia conduction. Catheter has to be removed/ replaced. Prologued initial anaesthesia procedure (approx. 15 minutes). No adverse outcome for the patient.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameEPILONG TUOHY
Type of DeviceANAESTHESIA CONDUCTION KIT, CONTINUOUS, EPIDURAL
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 Key7163134
MDR Text Key272789552
Report Number9611612-2018-00001
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,user f
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/02/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/04/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number0331152-51
Device Catalogue Number0331152-51
Device Lot Number1222
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/10/2018
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received01/02/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/26/2017
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: 01/04/2018 Patient Sequence Number: 1
-
-