MAUDE Adverse Event Report: PAJUNK GMBH MEDIZINTECHNOLOGIE SONOLONG; 868.5140 ANESTHESIA CONDUCTION KIT

Model Number 531185-31A

Device Problem Bent (1059)

Patient Problems Nerve Damage (1979); Perforation (2001)

Event Date 01/19/2015

Event Type  Injury  

Event Description

(b)(4).Event took place in (b)(6).Description provided by the customer: lot cannot easily retrace, currently 1092 is used.Description of the complaint see mail from prof.(b)(6) in the (b)(6), also stored in the crm.Even pictures are put in the crm insight into the activity of 20/01.At the puncture the nerve was already perforated with the cannula.Report to the authority is still open, patient is pilot and currently has more challenges in the thumb.At one patient, an axillary plexus catheter was installed since 4 days and should be removed today.This was not possible with a pull and the patient shows significant parasthesia in the thumb and forefinger after a stronger pull.In ultrasound could be seen, that is by this pull along the median nerve tissue and deeper located moved.A node was adopted.Together with our hand surgeon dr.(b)(6), we decided to operational exposure, which brought to an amazing day: the catheter perforated visible the median nerve; a few millimeters behind the perforation of the catheter was bent sharply.

• Brand Name: SONOLONG
• Type of Device: 868.5140 ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): PAJUNK GMBH MEDIZINTECHNOLOGIE; karl-hall-strasse 1; geisingen, baden-wuerttemberg 7818 7; GM 78187
• Manufacturer Contact: karl-hall-strasse 1; geisingen, baden-wuerttemberg 78187 ; 7049291586
• MDR Report Key: 4487311
• MDR Text Key: 5498999
• Report Number: 9611612-2015-00003
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• PMA/PMN Number: K13188
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Type of Report: Initial
• Report Date: 02/02/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 531185-31A
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/27/2015
• Date Manufacturer Received: 01/19/2015
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention