MAUDE Adverse Event Report: PAJUNK GMBH MEDIZINTECHNOLOGIE STIMULONG NANOLINE; ANESTHESIA CONDUCTION KIT

Model Number 531156-32C

Device Problems Break (1069); Detachment Of Device Component (1104)

Patient Problem Pain (1994)

Event Date 09/28/2017

Event Type  malfunction  

Event Description

Physician was placing a left infraclavicular catheter for relief of complex regional pain syndrome.The physician was unable to elicit nerve stimulation with the catheter that had been placed.As the catheter was being withdrawn a 7 cm distal section broke off.A new catheter was placed without incident or harm to the patient.

• Brand Name: STIMULONG NANOLINE
• Type of Device: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): PAJUNK GMBH MEDIZINTECHNOLOGIE; 6611 bay circle, suite 140; norcross , ga 30071 GA 30071
• MDR Report Key: 6957507
• MDR Text Key: 89591730
• Report Number: 6957507
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2017
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 11/30/2020
• Device Model Number: 531156-32C
• Device Catalogue Number: 531156-32C
• Device Lot Number: 1137
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/09/2017
• Device Age: 2 YR
• Event Location: Hospital
• Date Report to Manufacturer: 10/09/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 10 YR
• Patient Weight: 41