MAUDE Adverse Event Report: PAJUNK GMBH MEDIZINTECHNOLOGIE INFILTRALONG; ANAESTHESIA CONDUCTION CATHETER

Model Number	001158-20B
Medical Device Problem Codes	Material Rupture (1546); Material Split, Cut or Torn (4008)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); Device Embedded In Tissue or Plaque (3165)
Date of Event	02/07/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Event took place in (b)(6) and has been reported through (b)(4) distributor (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: at the remove of the catheter, the user tried at 3 times to remove, the catheter stayed blocked.After this insistence, the catheter has been broken.A no determinate longueur catheter is stayed inside the patient.
Event or Problem Description
Irn#: (b)(4).Summarizing tentative translation from initial reporter´s narrative: at the remove of the catheter, the user tried at 3 times to remove, the catheter stayed blocked.After this insistence, the catheter has been broken.A no determinate longueur catheter is stayed inside the patient.
Additional Manufacturer Narrative
The available data still is poor and the device has been disposed.Based on risk assessment and clinical evaluation report as well as substantiated by post market data this case is considered as closed.

• Brand Name: INFILTRALONG
• Common Device Name: ANAESTHESIA CONDUCTION CATHETER
• Manufacturer (Section D): PAJUNK GMBH MEDIZINTECHNOLOGIE; karl-hall-str. 1; tuttlinger str. 7; geisingen, baden-wuerttemberg 78187 ; GM 78187
• MDR Report Key: 8415335
• Report Number: 9611612-2019-00005
• Device Sequence Number: 1612482
• Product Code: BSO
• UDI-Device Identifier: 14048223016043
• UDI-Public: 14048223016043
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K080675
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 04/11/2019

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: Health Professional
• Device Model Number: 001158-20B
• Device Catalogue Number: 001158-20B
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/22/2019
• Supplement Date Received by Manufacturer: 02/22/2019
• Initial Report FDA Received Date: 03/13/2019
• Supplement Report FDA Received Date: 04/11/2019
• 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: Required Intervention