MAUDE Adverse Event Report: PAJUNK GMBH MEDIZINTECHNOLOGIE EPILONG TUOHY NERVE BLOCK KIT, EPIDURAL

Model Number 0531152-51

Device Problems Kinked (1339); Occlusion Within Device (1423); Material Integrity Problem (2978)

Patient Problem No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

Event took place in (b)(6) and has been reported through (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). Date of event unknown. Summarizing translation: after surgical intervention pain catheter was placed. After some time the catheter kinked/ catheter is too soft and was occluded. Happened many times.

Manufacturer Narrative

Based on risk assessment and clinical evaluation file is considered as closed. Device discarded by user.

Event Description

(b)(4). Date of event and device code/ batch in particular unknown. The device data submitted in this report has been rebuilt from plausible data based on supplier files and delivery notes. Summarizing translation: after surgical intervention pain catheter was placed. After some time the catheter kinked/ catheter is too soft and was occluded. Happened many times.

• Brand Name: EPILONG TUOHY
• Type of Device: NERVE BLOCK KIT, 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; regulatory & safety affairs; geisingen, baden-wuerttemberg 78187 ; GM 78187 ; 7704929158
• MDR Report Key: 5895900
• MDR Text Key: 52747380
• Report Number: 9611612-2016-00114
• 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: distributor

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 11/28/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 01/01/2021
• Device Model Number: 0531152-51
• Device Catalogue Number: 0531152-51
• Device Lot Number: 1145
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 08/15/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 08/23/2016 Patient Sequence Number: 1