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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PAJUNK GMBH MEDIZINTECHNOLOGIE EPISPIN LOCK CONTINUOUS COMBINED SPINAL EPIDURAL NERVE BLOCK KIT

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PAJUNK GMBH MEDIZINTECHNOLOGIE EPISPIN LOCK CONTINUOUS COMBINED SPINAL EPIDURAL NERVE BLOCK KIT Back to Search Results
Model Number 0021351-18
Device Problems Break (1069); Detachment Of Device Component (1104); Fracture (1260); Manufacturing, Packaging or Shipping Problem (2975)
Patient Problems Foreign Body In Patient (2687); Device Embedded In Tissue or Plaque (3165)
Event Date 12/18/2016
Event Type  Injury  
Manufacturer Narrative
Event took place in (b)(6) and has been reported through (b)(6) 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.
 
Event Description
(b)(4). Summarizing tentative translation from initial reporter´s narrative:upon removal of catheter after 2 days (48 hours) catheter ruptured/ broke of. Fragment was left with patient.
 
Manufacturer Narrative
Based on risk assessment and clinical evaluation file is considered as closed.
 
Event Description
(b)(4). Summarizing tentative translation from initial reporter´s narrative:upon removal of catheter after 2 days (48 hours) catheter ruptured/ broke of. Fragment was left with patient. Patient has been informed.
 
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Brand NameEPISPIN LOCK
Type of DeviceCONTINUOUS COMBINED SPINAL EPIDURAL 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 Key6197509
MDR Text Key63067590
Report Number9611612-2016-00162
Device Sequence Number1
Product Code CAZ
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K060563
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/13/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/22/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/01/2020
Device Model Number0021351-18
Device Catalogue Number0021351-18
Device Lot Number1140
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/09/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/19/2016
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: 12/22/2016 Patient Sequence Number: 1
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