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

Model Number 041151-604

Device Problems Fracture (1260); Device Handling Problem (3265)

Patient Problem Foreign Body In Patient (2687)

Event Date 08/15/2014

Event Type  Injury  

Manufacturer Narrative

Event took place in (b)(6) and has been reported through (b)(4).Based on risk assessment and clinical evaluation file is considered as closed.As soon as further significant data will be available, a follow up report will be sent in to the agency.We consider this file as closed.

Event Description

(b)(4).Event took place 3 years ago in (b)(6) and has been reported now by hospital/ patient´s advocate.On (b)(6) 2014 "h l.00 am", the anesthetist inserted a peridural catheter for labor analgesia on the patient.Positioning was easy and according to usual guidelines.At testing the dose of 2% lidocaine, the anesthetist could not inject the anesthetic; in the hypothesis that there may be obstruction at the filter level,she replaced it, but without any benefit.So she hypothesized it could be the obstruction of the catheter due to malposition (kneeling, loop), so she retracted and then removed it completely.At extraction, she found that the catheter was sliced about 6-7 cm from the tip, probably by the tuohy cannula tip.

• Brand Name: EPILONG TUOHY
• Type of Device: CONTINUOUS EPIDURAL ANAESTHESIA CONDUCTION KIT
• Manufacturer (Section D): PAJUNK GMBH MEDIZINTECHNOLOGIE; karl-hall-str. 1; geisingen, 78187 ; GM 78187
• Manufacturer (Section G): PAJUNK GMBH MEDIZINTECHNOLOGIE; karl-hall-str. 1; geisingen, 78187 ; GM 78187
• Manufacturer Contact: christian quass ; karl-hall-str. 1; geisingen, 78187 ; GM 78187
• MDR Report Key: 6874994
• MDR Text Key: 86558727
• Report Number: 9611612-2017-00008
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K060311
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 09/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: 041151-604
• Device Catalogue Number: 041151-604
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/15/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Required Intervention