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

Model Number 511156-31A

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 05/09/2016

Event Type  malfunction  

Manufacturer Narrative

Event took place in (b)(6) and has been reported through (b)(4) distribution subsidiary pajunk medical produkte (b)(4).Currently the data is poor and the device has not been sent back/ analysed.As soon as further data will be available a follow up report will be sent in to the agency.Not returned.

Event Description

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

Manufacturer Narrative

Based on risk assessment and clinical evaluation file is considered as closed.

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: 5688162
• MDR Text Key: 46171030
• Report Number: 9611612-2016-00072
• 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,Followup
• Report Date: 11/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/01/2021
• Device Model Number: 511156-31A
• Device Catalogue Number: 511156-31A
• Device Lot Number: 1151
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/23/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/13/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2016
• 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