MAUDE Adverse Event Report: PAJUNK GMBH MEDIZINTECHNOLOGIE EPILONG; ANAESTHESIA CONDUCTION CATHETER, EPIDURAL, CONTINUOUS INFUSION

Model Number 0331152-51

Device Problem Blocked Connection (2888)

Patient Problem Awareness during Anaesthesia (1707)

Event Date 03/07/2019

Event Type  malfunction  

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)(6).Tentative summarizing translation from initial reporter's narrative: distal end of catheter is closed.

• Brand Name: EPILONG
• Type of Device: ANAESTHESIA CONDUCTION CATHETER, EPIDURAL, CONTINUOUS INFUSION
• Manufacturer (Section D): PAJUNK GMBH MEDIZINTECHNOLOGIE; karl-hall-str. 1; tuttlinger str. 7; geisingen, baden-wuerttemberg 78187 ; GM 78187
• Manufacturer (Section G): PAJUNK GMBH MEDIZINTECHNOLOGIE; karl-hall-str. 1; tuttlinger str. 7; geisingen, baden-wuerttemberg 78187 ; GM 78187
• Manufacturer Contact: christian quass ; karl-hall-str. 1; tuttlinger str. 7; geisingen, baden-wuerttemberg 78187 ; GM 78187
• MDR Report Key: 8502929
• MDR Text Key: 141600022
• Report Number: 9611612-2019-00010
• Device Sequence Number: 1
• Product Code: CAZ
• UDI-Device Identifier: 14048223012991
• UDI-Public: 14048223012991
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K060311
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 04/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/17/2023
• Device Model Number: 0331152-51
• Device Catalogue Number: 0331152-51
• Device Lot Number: 1263
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/18/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/17/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other