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

Model Number 521156-31A

Device Problems Nonstandard Device (1420); Product Quality Problem (1506); Failure to Advance (2524); Device-Device Incompatibility (2919)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/15/2016

Event Type  malfunction  

Manufacturer Narrative

Event took place in (b)(6) and has been reported through (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.

Event Description

(b)(4).Summarizing tentative translation from initial reporter´s narrative: unable to advance catheter through needle.

Manufacturer Narrative

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

Event Description

(b)(4).Summarizing tentative translation from initial reporter´s narrative: unable to advance catheter through needle.

• Brand Name: PLEXOLONG NANOLINE
• Type of Device: PERIPHERAL NERVE BLOCK KIT, CONTINUOUS
• 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: 6201717
• MDR Text Key: 63611028
• Report Number: 9611612-2016-00163
• Device Sequence Number: 1
• Product Code: CAZ
• UDI-Device Identifier: 04048223009772
• UDI-Public: 04048223009772
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: 521156-31A
• 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: 04/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 04/01/2021
• Device Model Number: 521156-31A
• Device Catalogue Number: 521156-31A
• Device Lot Number: 1156
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/20/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/22/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2016
• 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