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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PAJUNK GMBH MEDIZINTECHNOLOGIE SONOLONG ECHO NANOLINE PERIPHERAL NERVE BLOCK KIT

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PAJUNK GMBH MEDIZINTECHNOLOGIE SONOLONG ECHO NANOLINE PERIPHERAL NERVE BLOCK KIT Back to Search Results
Model Number 521185-31C
Device Problems Fracture (1260); Device Handling Problem (3265)
Patient Problem Foreign Body In Patient (2687)
Event Date 07/26/2017
Event Type  Injury  
Event Description
(b)(4). From initial reporter´s narrative: (b)(6) year old child booked for modified raavitch repair. Preop consented for ga and bilateral paravertebral catheters for la infusion. No problems at induction and child turned into lateral position sbyb performed and left paravertebral catheter inserted under full aseptic precautions using 100mm sonoecho nerve block kit. Catheter was tunnelled under the skin and whilst being withdrawn to appropriate length it was noted to be sheared at 9 cm mark. Attempt to find the catheter by myself and mr (b)(6) failed and it was decided after discussion with dr (b)(6) to do a ct scan and locate the catheter position. Family was informed by myself and mr (b)(6) and all options given to them. Consent was obtained to surgically remove the sheared catheter if possible. The catheter location was identified under ct and surgically removed by a small incision in the back at the original entry point of insertion following further discussions with the family it was decided to go ahead with original surgical procedure. The various options of pain relief were considered and it was decided to insert bilateral paravertebral catheters which was uneventful surgery went smoothly and child was extubated at the end and transferred back to ic details of injury (to patient, carer or healthcare professional): consent was obtained to surgically remove the sheared catheter if possible. The catheter location was identified under ct and surgically removed by a small incision in the back at the original entry point of insertion. Action taken (includes any action by patient, carer or healthcare professional, or by the manufacturer or supplier) consent was obtained to surgically remove the sheared catheter if possible. The catheter location was identified under ct and surgically removed by a small incision in the back at the original entry point of insertion.
 
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Brand NameSONOLONG ECHO NANOLINE
Type of DevicePERIPHERAL NERVE BLOCK KIT
Manufacturer (Section D)
PAJUNK GMBH MEDIZINTECHNOLOGIE
karl-hall-str. 1
geisingen, 78187
GM 78187
Manufacturer (Section G)
PAJUNK GMBH MEDIZINTECHNOLOGIE
karl-hall-str. 1
geisingen, 78187
GM 78187
Manufacturer Contact
christian quass
karl-hall-str. 1
geisingen, 78187
GM   78187
MDR Report Key6829962
MDR Text Key83962680
Report Number9611612-2017-00007
Device Sequence Number1
Product Code CAZ
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K113188
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial
Report Date 08/30/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/30/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date02/28/2019
Device Model Number521185-31C
Device Catalogue Number521185-31C
Device Lot Number1056
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/24/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received08/04/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/01/2014
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: 08/30/2017 Patient Sequence Number: 1
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