MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON, TRACH-VENT, CLEAN; TRACH VENT HME

Catalog Number 41312

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)

Event Date 01/14/2015

Event Type  malfunction  

Event Description

The customer alleges that when prepping the trach-vent for use, she realized the self-opining/closing port for suction was dislocated in the vent itself.No pt injury.

Manufacturer Narrative

(b)(6).The device sample was not returned for evaluation at the time of this report.

• Brand Name: HUDSON, TRACH-VENT, CLEAN
• Type of Device: TRACH VENT HME
• Manufacturer (Section D): TELEFLEX MEDICAL; rtp NC
• Manufacturer (Section G): TELEFLEX MED; p.o. box 28, kamunting; industrial estate, kamunting; perak, west malaysia 3460 0; MY 34600
• Manufacturer Contact: margie burton, rn ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9194334965
• MDR Report Key: 4490709
• MDR Text Key: 5568096
• Report Number: 8040412-2015-00030
• Device Sequence Number: 1
• Product Code: CAH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/14/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/30/2019
• Device Catalogue Number: 41312
• Device Lot Number: 201427
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/14/2015
• 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