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.

Event Description

(b)(4).Summarizing tentative translation from initial reporter´s narrative: catheter rupture.150mm fragment remains with patient.

Manufacturer Narrative

Event took place in (b)(6) and has been reported through (b)(6).Based on risk management and clinical evaluation this file is considered as closed.(b)(4).

• 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
• MDR Report Key: 7246915
• MDR Text Key: 99185298
• Report Number: 9611612-2018-00013
• Device Sequence Number: 1
• Product Code: CAZ
• UDI-Device Identifier: 14048223009793
• UDI-Public: 14048223009793
• Combination Product (y/n): N
• PMA/PMN Number: K053283
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• 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: No Information
• Device Expiration Date: 05/22/2022
• 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
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/05/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention