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

Model Number	0531152-51
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Pain (1994); Foreign Body In Patient (2687)
Date of Event	08/03/2018
Type of Reportable Event	Serious Injury
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 returned/ 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)(4).Catheter torn apart, required intervention to remove fragment.
Event or Problem Description
Irn# (b)(4).Catheter torn apart, required intervention to remove fragment.
Additional 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
• Common Device Name: 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
• Report Number: 9611612-2018-00030
• Device Sequence Number: 1249666
• Product Code: CAZ
• UDI-Device Identifier: 14048223013158
• UDI-Public: 14048223013158
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K060311
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/12/2018

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?: No
• Operator of Device: 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
• Initial Date Received by Manufacturer: 08/03/2018
• Supplement Date Received by Manufacturer: 08/03/2018
• Initial Report FDA Received Date: 08/23/2018
• Supplement Report FDA Received Date: 09/12/2018
• 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; Required Intervention