MAUDE Adverse Event Report: PAJUNK GMBH MEDIZINTECHNOLOGIE PLEXOLONG NANOLINE; PERIPHERAL NERVE BLOCK KIT

Model Number 531156-31A

Device Problems Component Incompatible (1108); Component or Accessory Incompatibility (2897); Human Factors Issue (2948); Human-Device Interface Problem (2949); Compatibility Problem (2960)

Patient Problem Awareness during Anaesthesia (1707)

Event Date 02/25/2016

Event Type  malfunction  

Manufacturer Narrative

Event took place in (b)(6).Unfortunately, the device has been disposed.We consider this file as closed.Device not returned, disposed.

Event Description

(b)(4).Summarizing translation of user/ reporter narrative: unable to advance the catheter through the needle.

• Brand Name: PLEXOLONG NANOLINE
• 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: 5503644
• MDR Text Key: 40407470
• Report Number: 9611612-2016-00034
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K053283
• 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
• Report Date: 03/16/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 531156-31A
• Device Catalogue Number: 531156-31A
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/07/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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