MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON TRACH-VENT+,CLEAN; CONDENSER, HEAT AND MOISTURE

Catalog Number G41312

Device Problem Material Separation (1562)

Patient Problems Dyspnea (1816); No Consequences Or Impact To Patient (2199)

Event Date 12/07/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device involved in this complaint has not been received by the manufacturer at the time of this report.The investigation into this complaint is still in progress.

Event Description

Customer complaint alleges "the silicone valve came off and fell into the housing." alleged issue reported as occurring during use.It was reported the patient experienced a short episode of dyspnea which quickly resolved by replacing the device right away with a new one.Patient condition reported as "good with no additional injury reported.".

Manufacturer Narrative

(b)(4).A device history record (dhr) review was performed and there were no issues found that could relate to the reported complaint.The sample was returned for evaluation.A visual exam was performed and it was observed that there was an extra silicone valve in the product housing.The silicone valve blocked the airway in the housing thus causing poor oxygen supply to the patient.The extra silicone valve found in the product housing was caused by operators inadvertently failing to detect it during the assembly process.A non-conformance was opened to address this issue.

Event Description

Customer complaint alleges "the silicone valve came off and fell into the housing." alleged issue reported as occurring during use.It was reported the patient experienced a short episode of dyspnea which quickly resolved by replacing the device right away with a new one.Patient condition reported as "good with no additional injury reported.".

• Brand Name: HUDSON TRACH-VENT+,CLEAN
• Type of Device: CONDENSER, HEAT AND MOISTURE
• Manufacturer (Section D): TELEFLEX MEDICAL; perak, west malaysia
• Manufacturer (Section G): TELEFLEX MEDICAL; po box 28, kamunting industrial estate; perak, west malaysia 34600 ; MY 34600
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9194334854
• MDR Report Key: 7156560
• MDR Text Key: 96228874
• Report Number: 8040412-2018-00001
• Device Sequence Number: 1
• Product Code: BYD
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: G41312
• Device Lot Number: 201715J
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/26/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/11/2017
• Initial Date FDA Received: 01/02/2018
• Supplement Dates Manufacturer Received: 02/07/2018
• Supplement Dates FDA Received: 02/07/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2017
• 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