MAUDE Adverse Event Report: PAJUNK GMBH MEDIZINTECHNOLOGIE EPILONG TUOHY; KIT FOR CONTINUOUS EPIDURAL ANAESTHESIA AND ANALGESIA

Model Number 0531152-51

Device Problem Fracture (1260)

Patient Problems Pain (1994); Foreign Body In Patient (2687)

Event Date 08/03/2018

Event Type  Injury  

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 returned/ analysed.As soon as further data will be available a follow up report will be sent in to the agency.

Event Description

(b)(4).Catheter torn apart, required intervention to remove fragment.

Event Description

Irn# (b)(4).Catheter torn apart, required intervention to remove fragment.

Manufacturer Narrative

Based on risk assessment and clinical evaluation case is considered as closed.Attachment: [2018-08-18_complaint report for 278-18.Pdf].

• Brand Name: EPILONG TUOHY
• Type of Device: KIT FOR CONTINUOUS EPIDURAL ANAESTHESIA AND ANALGESIA
• Manufacturer (Section D): PAJUNK GMBH MEDIZINTECHNOLOGIE; karl-hall-str. 1; tuttlinger str. 7; geisingen, baden-wuerttemberg 78187 ; GM 78187
• MDR Report Key: 7808035
• MDR Text Key: 117959075
• Report Number: 9611612-2018-00030
• Device Sequence Number: 1
• Product Code: CAZ
• UDI-Device Identifier: 14048223013158
• UDI-Public: 14048223013158
• Combination Product (y/n): N
• PMA/PMN Number: K060311
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 09/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/29/2022
• Device Model Number: 0531152-51
• Device Catalogue Number: 0531152-51
• Device Lot Number: 1227
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/20/2018
• Date Manufacturer Received: 08/03/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention