MAUDE Adverse Event Report: PAJUNK GMBH MEDIZINTECHNOLOGIE EPILONG TUOHY; ANESTHESIA CONDUCTION CATHETER

Model Number 0531152-51

Device Problems Partial Blockage (1065); Product Quality Problem (1506)

Patient Problems Awareness during Anaesthesia (1707); No Known Impact Or Consequence To Patient (2692)

Event Date 08/19/2015

Event Type  malfunction  

Manufacturer Narrative

Device has not yet been returned to manufacturer but is announced to be sent back for investigation.This report initially has been sent via postal mail due to technical problems in establishing emdr properly.Upon request by medical device reporting team dated 2016-02-12 this report is re-sent via webtrader emdr-module.Not returned.

Event Description

Exact date of event unknown, reported 2015-08-19 to company representative (b)(4).Event took place in (b)(6) tentative summarizing translation from users narrative: upon injection through epidural catheter it was noticed the catheter was blocked.Upon investigation 2 of 3 lateral openings were not fully open.

Manufacturer Narrative

This report initially has been sent via postal mail due to technical problems in establishing emdr properly.Upon request by medical device reporting team dated 2016-02-12 this report is re-sent via webtrader emdr-module.

Event Description

Exact date of event unknown, reported (b)(6) 2015 to company representative.(b)(4).Event took place in (b)(6).Tentative summarizing translation from users narrative: upon injection through epidural catheter it was noticed the catheter was blocked.Upon investigation 2 of 3 lateral openings were not fully open.

• Brand Name: EPILONG TUOHY
• Type of Device: ANESTHESIA CONDUCTION CATHETER
• 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; regulatory & safety affairs; geisingen, baden-wuerttemberg 78187 ; GM 78187 ; 7704929158
• MDR Report Key: 5443136
• MDR Text Key: 39036634
• Report Number: 9611612-2015-00008
• Device Sequence Number: 1
• Product Code: BSO
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 10/01/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/01/2019
• Device Model Number: 0531152-51
• Device Catalogue Number: 0531152-51
• Device Lot Number: 1094
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/15/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/24/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2015
• 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