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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PAJUNK GMBH MEDIZINTECHNOLOGIE PLEXOLONG NANOLINE PERIPHERAL NERVE BLOCK KIT

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PAJUNK GMBH MEDIZINTECHNOLOGIE PLEXOLONG NANOLINE PERIPHERAL NERVE BLOCK KIT Back to Search Results
Model Number 511156-31A
Device Problems Component Incompatible (1108); Component or Accessory Incompatibility (2897); Human Factors Issue (2948); Human-Device Interface Problem (2949); Compatibility Problem (2960)
Patient Problem Awareness during Anaesthesia (1707)
Event Date 05/09/2016
Event Type  malfunction  
Manufacturer Narrative
Event took place in (b)(6) and has been reported through (b)(4) distribution subsidiary pajunk medical produkte (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. Not returned.
 
Event Description
Internal report-number: (b)(4). Summarizing translation of user/ reporter narrative: unable to advance the catheter through the needle.
 
Manufacturer Narrative
Based on risk assessment and clinical evaluation file is considered as closed.
 
Event Description
(b)(4). Summarizing translation of user/ reporter narrative: unable to advance the catheter through the needle.
 
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Brand NamePLEXOLONG NANOLINE
Type of DevicePERIPHERAL NERVE BLOCK 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 Key5688162
MDR Text Key46171030
Report Number9611612-2016-00072
Device Sequence Number1
Product Code CAZ
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K053283
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 11/14/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/31/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/01/2021
Device Model Number511156-31A
Device Catalogue Number511156-31A
Device Lot Number1151
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/23/2016
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/13/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/01/2016
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: 05/31/2016 Patient Sequence Number: 1
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