MAUDE Adverse Event Report: PAJUNK GMBH MEDIZINTECHNOLOGIE EPILONG TUOHY; ANAESTHESIA CONDUCTION KIT, CONTINUOUS, EPIDURAL

Model Number	0331152-51
Medical Device Problem Codes	Nonstandard Device (1420); Product Quality Problem (1506); Device Misassembled During Manufacturing /Shipping (2912); No Flow (2991)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	12/28/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Event took place in (b)(6) and has been reported through (b)(4) distribution subsidiary (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)(4).Summarizing translation from initial reporter´s narrative: the epidural catheter is lacking the distal central opening.No anaesthesia conduction.Catheter has to be removed/ replaced.Prologued initial anaesthesia procedure (approx.15 minutes).No adverse outcome for the patient.
Additional Manufacturer Narrative
Based on risk management and clinical evaluation this incident is considered as closed.(b)(4).
Event or Problem Description
(b)(4).Summarizing translation from initial reporter´s narrative: the epidural catheter is lacking the distal central opening.No anaesthesia conduction.Catheter has to be removed/ replaced.Prologued initial anaesthesia procedure (approx.15 minutes).No adverse outcome for the patient.

• Brand Name: EPILONG TUOHY
• Common Device Name: ANAESTHESIA CONDUCTION KIT, CONTINUOUS, EPIDURAL
• Manufacturer (Section D): PAJUNK GMBH MEDIZINTECHNOLOGIE; karl-hall-str. 1; geisingen, baden-wuerttemberg 78187 ; GM 78187
• MDR Report Key: 7163134
• Report Number: 9611612-2018-00001
• Device Sequence Number: 1773253
• Product Code: CAZ
• UDI-Device Identifier: 14048223012991
• UDI-Public: 14048223012991
• 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,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/02/2018

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?: Yes
• Operator of Device: Other
• Device Expiration Date: 09/25/2022
• Device Model Number: 0331152-51
• Device Catalogue Number: 0331152-51
• Device Lot Number: 1222
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/10/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/02/2018
• Supplement Date Received by Manufacturer: 01/02/2018
• Initial Report FDA Received Date: 01/04/2018
• Supplement Report FDA Received Date: 02/02/2018
• 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