MAUDE Adverse Event Report: ANDREAS FAHL MEDIZINTECHNIK VERTRIEB GMBH DURAVENT XL; TRACHEOSTOMY TUBE

Model Number 21269-08

Device Problem Detachment Of Device Component (1104)

Patient Problems Hemorrhage/Bleeding (1888); Discomfort (2330)

Event Date 10/22/2016

Event Type  malfunction  

Manufacturer Narrative

Based on the investigation of the returned device and the information provided by the local distributor, we evaluate this issue as follows: according to the physical appearance of the device and the given information, the period of application was longer than instructed in the ifu as the maximum.Additionally the patient used other cleaning agents as prescribed in the cleaning instructions, which most likely might have taken an abrasive effect to the material.Conclusion: no indication for a product error found.An application error has to be assumed.The neck plate of the tracheostomy tube is located outside the body (non-invasive) and therefore the alleged detachment of the nack plate cannot have caused the asserted bleedings.A detaching of the tube from the neck plate is a long-term process and will not happen all at once.Several warnings in the enclosed ifu state that the device may not be used any longer, if the material of the device appears to be discoloured or damaged.Additional explanation: the reporting of this matter was delayed due to electronic reporting issues and the report is now being submitted on february 17, 2017 following the resolution of those issues on february 13, 2017.

Event Description

Andreas fahl (b)(4) received a complaint from a local distributor that a patient visited a physician for changing the tracheostomy tube, because the neck plate of the inserted tracheostomy tube started detaching.The reporter stated that the exchange of the outer cannula caused bleedings and discomfort to the patient.

• Brand Name: DURAVENT XL
• Type of Device: TRACHEOSTOMY TUBE
• Manufacturer (Section D): ANDREAS FAHL MEDIZINTECHNIK VERTRIEB GMBH; august-horch-str. 4a; cologne, nrw 51149 ; GM 51149
• Manufacturer Contact: august-horch-strasse 4a; cologne, nrw 51149 ; 220329800
• MDR Report Key: 6338864
• MDR Text Key: 68011768
• Report Number: 3007913402-2017-00002
• Device Sequence Number: 1
• Product Code: BTO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K123699
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Remedial Action: Notification
• Type of Report: Initial
• Report Date: 02/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/31/2021
• Device Model Number: 21269-08
• Device Lot Number: 02032016-GE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/21/2016
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Date Manufacturer Received: 10/31/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/02/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention