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

Model Number 531156-31A

Device Problems Break (1069); Fracture (1260); Material Fragmentation (1261); Material Rupture (1546)

Patient Problems Awareness during Anaesthesia (1707); No Known Impact Or Consequence To Patient (2692)

Event Date 01/20/2016

Event Type  malfunction  

Manufacturer Narrative

Follow up report will be sent as soon as device/ further information becomes available.

Event Description

(b)(4).Event took place in (b)(6) and has been reported to (b)(6).User narrative: breaking of catheter.Incision to retrieve the catheter portion remained in the patient.

Manufacturer Narrative

This file is considered as closed.

Event Description

Internal report-number: (b)(4).Tentative, summarizing translation from user's narrative: breaking of catheter, incision required to retrieve the catheter's fragment which got lost in the patient; fully retrieved.

• 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: 5433627
• MDR Text Key: 38760977
• Report Number: 9611612-2016-00003
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K023218
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/06/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 04/01/2020
• Device Model Number: 531156-31A
• Device Catalogue Number: 531156-31A
• Device Lot Number: 1113
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/23/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/11/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2015
• 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; Required Intervention