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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 531187-31B
Device Problems Improper or Incorrect Procedure or Method (2017); Device Handling Problem (3265)
Patient Problems Pain (1994); Foreign Body In Patient (2687)
Event Date 05/18/2017
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: 531187-31b sonolong sono 53118731bb sonolong nanoline punktionskanüle upon removal of the catheter, the metal coil was withdrawn distally from the catheter and remained in the patient. Small incision had to be made to remove fragment immediately.
 
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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 Key6633055
MDR Text Key77286249
Report Number9611612-2017-00004
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 06/12/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/12/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Other
Device Expiration Date11/21/2021
Device Model Number531187-31B
Device Catalogue Number531187-31B
Device Lot Number1182
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/07/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/19/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/22/2016
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: 06/12/2017 Patient Sequence Number: 1
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