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

Model Number 0331152-51

Device Problems Nonstandard Device (1420); Product Quality Problem (1506); Device Misassembled During Manufacturing /Shipping (2912); No Flow (2991)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 12/28/2017

Event Type  malfunction  

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 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.

Manufacturer Narrative

Based on risk management and clinical evaluation this incident is considered as closed.(b)(4).

Event 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
• Type of Device: ANAESTHESIA CONDUCTION KIT, CONTINUOUS, EPIDURAL
• Manufacturer (Section D): PAJUNK GMBH MEDIZINTECHNOLOGIE; karl-hall-str. 1; geisingen, baden-wuerttemberg 78187 ; GM 78187
• Manufacturer (Section G): PAJUNK GMBH MEDIZINTECHNOLOGIE; karl-hall-str. 1; geisingen, baden-wuerttemberg 78187 ; GM 78187
• Manufacturer Contact: christian quass ; karl-hall-str. 1; geisingen, baden-wuerttemberg 78187 ; GM 78187
• MDR Report Key: 7163134
• MDR Text Key: 96707398
• Report Number: 9611612-2018-00001
• Device Sequence Number: 1
• Product Code: CAZ
• UDI-Device Identifier: 14048223012991
• UDI-Public: 14048223012991
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K060311
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/02/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/26/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other