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

Model Number	0331152-51
Medical Device Problem Code	Blocked Connection (2888)
Health Effect - Clinical Code	Awareness during Anaesthesia (1707)
Date of Event	03/07/2019
Type of Reportable Event	Malfunction
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)(6).Tentative summarizing translation from initial reporter's narrative: distal end of catheter is closed.

• Brand Name: EPILONG
• Common Device Name: 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
• MDR Report Key: 8502929
• Report Number: 9611612-2019-00010
• Device Sequence Number: 1628733
• Product Code: CAZ
• UDI-Device Identifier: 14048223012991
• UDI-Public: 14048223012991
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K060311
• 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
• 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 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/18/2019
• Initial 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: Other