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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PAJUNK GMBH MEDIZINTECHNOLOGIE INTRALONG CATHETER ANASETHESIA CONDUCTION, SPINAL

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PAJUNK GMBH MEDIZINTECHNOLOGIE INTRALONG CATHETER ANASETHESIA CONDUCTION, SPINAL Back to Search Results
Model Number 31151-30GS
Device Problem Fracture (1260)
Patient Problem Foreign Body In Patient (2687)
Event Date 10/20/2017
Event Type  Injury  
Manufacturer Narrative
Event took place in (b)(6) and has been reported through (b)(6) distributor. Based on risk assessment and clinical evaluation file is considered as closed.
 
Event Description
(b)(4). Summarizing tentative translation from initial reporter´s narrative: the catheter is very elastic but gently pulled out until it drops the skin with a slight odor. I think it looks like it's broken at the end and contacts the anesthetist. After completion of the wake up, the patient should be ct scanned for further planning. " the patient got the catheter removed operatively.
 
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Brand NameINTRALONG
Type of DeviceCATHETER ANASETHESIA CONDUCTION, SPINAL
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
geisingen, baden-wuerttemberg 78187
GM   78187
MDR Report Key7057665
MDR Text Key92851760
Report Number9611612-2017-00015
Device Sequence Number1
Product Code CAZ
Combination Product (y/n)N
Reporter Country CodeDA
PMA/PMN Number
K082183
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Reporter Occupation
Type of Report Initial
Report Date 11/24/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/24/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date09/01/2021
Device Model Number31151-30GS
Device Catalogue Number31151-30GS
Device Lot Number1175
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received11/03/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/04/2016
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: 11/24/2017 Patient Sequence Number: 1
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