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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PAJUNK GMBH MEDIZINTECHNOLOGIE SONOLONG CURL SONO PERIPHERAL ANAESTHESIA CONDUCTION CATHETER

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PAJUNK GMBH MEDIZINTECHNOLOGIE SONOLONG CURL SONO PERIPHERAL ANAESTHESIA CONDUCTION CATHETER Back to Search Results
Model Number 521188-34C
Device Problem Device Handling Problem (3265)
Patient Problem Foreign Body In Patient (2687)
Event Date 09/27/2017
Event Type  Injury  
Manufacturer Narrative
Based on risk assessment and clinical evaluation file is considered as closed.
 
Event Description
(b)(4). From initial reporter: (b)(6) clinic was given to a patient rectus sheet block on both sides after a gynecological surgery for pain management on (b)(6) 2017 with pajunk sonolong curl echo catheters purchased from mediq (b)(4). The procedure went smoothly. On (b)(6) 2017 catheters were removed from the upper abdomen. The nurse removed the second catheter without any problems, but in another catheter there seemed to be a resistance. When pulling the catheter, it really felt a resistance and mild pain in the upper abdomen, and pulling the catheter continued until the white catheter came out of the skin. From the inside of the catheter appeared a frustrated metal wire-like line that stretched and stretched until it broke. There was apparently the catheter's head in the patient because the black point on the tip was missing from the out coming catheter. There was also left an unknown number of steel helical coil in the patient. It was suspected that the catheter's head would have gone into node because the injection site was such that the catheter would not be able to stick to any structure.
 
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Brand NameSONOLONG CURL SONO
Type of DevicePERIPHERAL ANAESTHESIA CONDUCTION CATHETER
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 Key7163625
MDR Text Key96341034
Report Number9611612-2018-00005
Device Sequence Number1
Product Code CAZ
Combination Product (y/n)N
Reporter Country CodeFI
PMA/PMN Number
K113188
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Reporter Occupation
Type of Report Initial
Report Date 01/04/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/04/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number521188-34C
Device Catalogue Number521188-34C
Device Lot NumberUNKNOWN
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 Received01/02/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 01/04/2018 Patient Sequence Number: 1
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