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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PAJUNK GMBH MEDIZINTECHNOLOGIE STIMULONG SONO TSUI NERVE BLOCK KIT, PERIPHERAL AND EPIDURAL USE

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PAJUNK GMBH MEDIZINTECHNOLOGIE STIMULONG SONO TSUI NERVE BLOCK KIT, PERIPHERAL AND EPIDURAL USE Back to Search Results
Model Number 521156-35U
Device Problems Break (1069); Detachment Of Device Component (1104); Fracture (1260); Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017); Device Handling Problem (3265)
Patient Problem Foreign Body In Patient (2687)
Event Date 07/18/2016
Event Type  Injury  
Manufacturer Narrative
At this time the information available is very poor. Neither the device nor the lot's have been identified clearly. User facility asked mfr to send a report to fda asap. As soon as more details will become available a follow up report will be sent in to the fda.
 
Event Description
(b)(4). Summary from user's narrative: sheered a tsui catheter in a pediatric patient spine. They performed a caudal block for a cancer patient. They had to perform surgery to remove the catheter (4 inch piece sheared off).
 
Manufacturer Narrative
At this time, the information available is still poor. Neither the device nor the lot# have been identified clearly. User facility asked mfr to send a report to fda asap. As soon as more details will become available, a follow up report will be sent in to the fda.
 
Event Description
Internal report-number: (b)(4). Hospital reported sonolong tsui catheter sheared and remained in patient. Patient was taken in the or for catheter retrieval.
 
Manufacturer Narrative
Based on risk assessment and clinical evaluation file is considered as closed.
 
Event Description
(b)(4). Hospital reported sonolong tsui catheter sheared and remained in patient. Patient was taken in the or for catheter retrieval.
 
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Brand NameSTIMULONG SONO TSUI
Type of DeviceNERVE BLOCK KIT, PERIPHERAL AND EPIDURAL USE
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 Key5814723
MDR Text Key50176699
Report Number9611612-2016-00104
Device Sequence Number1
Product Code CAZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K062900
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 11/14/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/21/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/01/2018
Device Model Number521156-35U
Device Catalogue Number521156-35U
Device Lot Number1044
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/21/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/01/2013
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: 07/21/2016 Patient Sequence Number: 1
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