MAUDE Adverse Event Report: PAJUNK GMBH MEDIZINTECHNOLOGIE EPILONG TUOHY; ANAESTHESIA CONDUCTION NEEDLE, CATHETER PLACEMENT

Model Number	0631152-51
Medical Device Problem Code	Loss of or Failure to Bond (1068)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/02/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Event took place in (b)(6), and has been reported through (b)(6).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
Irn#: (b)(4).Initial reporter´s narrative: after placing the tuohy needle tip in the epidural space, while removing the stylet from the needle, the plastic hub of the needle (including the wings) has completely fallen off.The needle had to be removed five minutes after using a sterile clamp of the surgeons.

• Brand Name: EPILONG TUOHY
• Common Device Name: ANAESTHESIA CONDUCTION NEEDLE, CATHETER PLACEMENT
• Manufacturer (Section D): PAJUNK GMBH MEDIZINTECHNOLOGIE; karl-hall-str. 1; tuttlinger str. 7; geisingen, 78187 ; GM 78187
• MDR Report Key: 9231206
• Report Number: 9611612-2019-00029
• Device Sequence Number: 19480179
• Product Code: CAZ
• UDI-Device Identifier: 14048223021443
• UDI-Public: 14048223021443
• 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): 10/24/2019

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: 04/01/2026
• Device Model Number: 0631152-51
• Device Catalogue Number: 1150-6K091
• Device Lot Number: 1296
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/09/2019
• Initial Report FDA Received Date: 10/24/2019
• 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