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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PAJUNK GMBH MEDIZINTECHNOLOGIE SONOLONG PERIPHERAL NERVE BLOCK CATHETER KIT

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PAJUNK GMBH MEDIZINTECHNOLOGIE SONOLONG PERIPHERAL NERVE BLOCK CATHETER KIT Back to Search Results
Model Number 521187-31B
Device Problems Improper or Incorrect Procedure or Method (2017); Device Handling Problem (3265)
Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Event Date 05/01/2017
Event Type  Injury  
Manufacturer Narrative
Based on risk assessment and clinical evaluation file is considered as closed.
 
Event Description
(b)(4). From initial reporter´s narrative: 521187-31b sonolong sono upon removal of the catheter, the metal coil was withdrawn proximally from the catheter. Catheter was used as intended without inner coil.
 
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Brand NameSONOLONG
Type of DevicePERIPHERAL NERVE BLOCK CATHETER KIT
Manufacturer (Section D)
PAJUNK GMBH MEDIZINTECHNOLOGIE
karl-hall-str. 1
geisingen, 78187
GM 78187
Manufacturer (Section G)
PAJUNK GMBH MEDIZINTECHNOLOGIE
karl-hall-str. 1
geisingen, 78187
GM 78187
Manufacturer Contact
christian quass
karl-hall-str. 1
geisingen, 78187
GM   78187
MDR Report Key6652843
MDR Text Key77914754
Report Number9611612-2017-00005
Device Sequence Number1
Product Code CAZ
Combination Product (y/n)N
Reporter Country CodeAU
PMA/PMN Number
K113188
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Reporter Occupation
Type of Report Initial
Report Date 06/20/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/20/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Other
Device Expiration Date05/01/2021
Device Model Number521187-31B
Device Catalogue Number521187-31B
Device Lot Number1163
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/12/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/01/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/01/2016
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: 06/20/2017 Patient Sequence Number: 1
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