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

Model Number 531185-31A

Device Problems Difficult to Insert (1316); Product Quality Problem (1506); Device Misassembled During Manufacturing /Shipping (2912); Physical Property Issue (3008)

Patient Problem Awareness during Anaesthesia (1707)

Event Type  malfunction  

Manufacturer Narrative

Event took place in (b)(6).At this time information on the device and the incident is poor.Follow up will be sent as soon as more information becomes available.Not returned.

Event Description

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

Manufacturer Narrative

File is considered as closed.

Event Description

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

• 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: 5446655
• MDR Text Key: 39104409
• Report Number: 9611612-2016-00013
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 05/12/2016

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: Physician
• Device Model Number: 531185-31A
• Device Catalogue Number: 531185-31A
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/22/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other