• 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 SONOLONG SONO PERIPHERAL NERVE BLOCK 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 SONOLONG SONO PERIPHERAL NERVE BLOCK KIT Back to Search Results
Model Number 521187-31C
Device Problems Fracture (1260); Improper or Incorrect Procedure or Method (2017); Device Handling Problem (3265)
Patient Problem Foreign Body In Patient (2687)
Event Date 01/12/2017
Event Type  Injury  
Manufacturer Narrative
We got aware of this reported event through regular maude database research on february 10th 2017. Tried to identify initial reporter/ user facility through distributor listed in report ((b)(4)). Unable to exactly identify user facility. February 28th we received fda´s notice with further details (user facility´s report number mw5067820) but still are unable to identify user facility. 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. Based on risk assessment and clinical evaluation, file is considered as closed if no further information becomes available. Device not returned.
 
Event Description
(b)(4). From database and report submitted by fda: used pajunk sonolong kit for adductor continuous block. Difficult to thread catheter. Attempted to remove catheter through needle and 2cm catheter sheared off and was retained in the patient´s thigh. No intervention needed unless patient develops subsequent problems. While pulling the catheter back into the needle, to readjust its position. The tip of the catheter broke off into the patient (a 2 cm piece). The physician and the surgeon discussed the risks and benefits of operating the site to find and remove the catheter versus leaving it in. The decision was to leave it in.
 
Manufacturer Narrative
This follow up is filed due to an error in the initial report. There has been a mixup of complaint numbers assigned. This follow up corrects the fals and misleading information contained in the initial report. The actual device has been evaluated and the final evaluation report is part of this submission of a follow up report. February 28th we received fda´s notice with further details (user facility's report number mw5067820) but still are unable to identify user facility. Based on risk assessment and clinical evaluation, file is considered as closed if no further information becomes available.
 
Event Description
(b)(4). From database and report submitted by fda: used pajunk sonolong kit for adductor continuous block. Difficult to thread catheter. Attempted to remove catheter through needle and 2cm catheter sheared off and was retained in the patient´s thigh. No intervention needed unless patient develops subsequent problems. While pulling the catheter back into the needle, to readjust its position. The tip of the catheter broke off into the patient (a 2 cm piece). The physician and the surgeon discussed the risks and benefits of operating the site to find and remove the catheter versus leaving it in. The decision was to leave it in.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameSONOLONG SONO
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 Key6363422
MDR Text Key68465071
Report Number9611612-2017-00003
Device Sequence Number1
Product Code CAZ
Combination Product (y/n)N
Reporter Country CodeUS
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,Followup
Report Date 03/01/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/28/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date11/01/2020
Device Model Number521187-31C
Device Catalogue Number521187-31C
Device Lot Number1137
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/20/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/10/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/01/2015
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: 02/28/2017 Patient Sequence Number: 1
-
-