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

Model Number	521156-31C
Medical Device Problem Codes	Fracture (1260); Material Rupture (1546)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	01/11/2018
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
(b)(4).Summarizing tentative translation from initial reporter´s narrative: catheter rupture.A 150mm fragment remains with patient.
Event or Problem Description
(b)(4).Summarizing tentative translation from initial reporter´s narrative: catheter rupture.150mm fragment remains with patient.
Additional 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
• Common Device Name: 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
• Report Number: 9611612-2018-00013
• Device Sequence Number: 13794970
• Product Code: CAZ
• UDI-Device Identifier: 14048223009793
• UDI-Public: 14048223009793
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K053283
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: 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
• Initial Date Received by Manufacturer: 02/05/2018
• Supplement Date Received by Manufacturer: 02/05/2018
• Initial Report FDA Received Date: 02/07/2018
• Supplement Report FDA Received Date: 04/11/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention