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.

• 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
• Manufacturer (Section G): PAJUNK GMBH MEDIZINTECHNOLOGIE; karl-hall-str. 1; tuttlinger str. 7; geisingen, baden-wuerttemberg 78187 ; GM 78187
• Manufacturer Contact: christian quass ; 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
• 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,distri
• Reporter Occupation: Other Health Care Professional
• 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

• 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
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 08/03/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/30/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No

Type of Device Usage

Patient Treatment Data

Date Received: 08/23/2018 Patient Sequence Number: 1