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

Model Number 001158-20B

Device Problems Material Rupture (1546); Material Split, Cut or Torn (4008)

Patient Problems No Known Impact Or Consequence To Patient (2692); Device Embedded In Tissue or Plaque (3165)

Event Date 02/07/2019

Event Type  Injury  

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 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 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.

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
• Type of Device: 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
• MDR Text Key: 138645724
• Report Number: 9611612-2019-00005
• Device Sequence Number: 1
• Product Code: BSO
• UDI-Device Identifier: 14048223016043
• UDI-Public: 14048223016043
• Combination Product (y/n): N
• PMA/PMN Number: K080675
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 04/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 001158-20B
• Device Catalogue Number: 001158-20B
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention