MAUDE Adverse Event Report: PAJUNK GMBH MEDIZINTECHNOLOGIE PLEXOLONG NANOLINE KIT CONTINUOUS PERIPHERAL ANAESTHESIA CONDUCTION KIT

Model Number 521156-31C

Device Problems Fracture (1260); Material Rupture (1546)

Patient Problem Foreign Body In Patient (2687)

Event Date 01/11/2018

Event Type  Injury  

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: catheter rupture. A 150mm fragment remains with patient.

• Brand Name: PLEXOLONG NANOLINE KIT
• Type of Device: CONTINUOUS PERIPHERAL ANAESTHESIA CONDUCTION 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; geisingen, baden-wuerttemberg 78187 ; GM 78187
• MDR Report Key: 7246915
• MDR Text Key: 99185298
• Report Number: 9611612-2018-00013
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K053283
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 04/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 521156-31C
• Device Catalogue Number: 521156-31C
• Device Lot Number: 1207
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/05/2018
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Event Location: No Information
• Date Manufacturer Received: 02/05/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/23/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 02/07/2018 Patient Sequence Number: 1