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

Model Number 531185-31A

Device Problems Kinked (1339); Nonstandard Device (1420); Product Quality Problem (1506); Device Misassembled During Manufacturing /Shipping (2912)

Patient Problems Awareness during Anaesthesia (1707); No Information (3190)

Event Date 01/15/2016

Event Type  malfunction  

Manufacturer Narrative

Event took place in (b)(6). At this time information on the device and the incident is poor. No information about the device´s whereabout. Follow up will be sent as soon as more information becomes available. Not returned.

Event Description

(b)(4). Users narrative tentative translation: catheter does not go smoothly through needle, kinks.

Manufacturer Narrative

Event took place in (b)(6). Isolated event. File is considered as closed.

Event Description

Internal report number: (b)(4). Users narrative tentative translation: catheter does not go smoothly through needle, kinks.

• Brand Name: SONOLONG ECHO
• Type of Device: PERIPHERAL 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 Key: 5446648
• MDR Text Key: 39039179
• Report Number: 9611612-2016-00017
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K113188
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 06/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 08/01/2017
• Device Model Number: 531185-31A
• Device Catalogue Number: 531185-31A
• Device Lot Number: 984
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2016
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 01/26/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2012
• 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: 02/19/2016 Patient Sequence Number: 1