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

Catalog Number 41312

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Foreign Body In Patient (2687)

Event Date 12/04/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Additional information received from the customer reports: "the membrane could be removed out of patient without problems.Patient was not injured, only a slight mucous membrane irritation was noted." "customer confirmed on phone on (b)(6) 2017 that the bronchoscopy was not specifically to look for a foreign body.The foreign part was noticed by chance during this process control.It is unknown how long the part was in the patient's lung".The device has been received for investigation.However the investigation of said device has not concluded at the time of this report.

Event Description

Complaint alleges: "during a bronchoscopy, a foreign object was found in the right main bronchus and removed.The foreign object is a part of the suction port of the artificial nose - more precisely, the closing membrane." it was reported "the patient didn't suffer any damage." customer reports patient condition as "fine".

Event Description

Complaint complaint alleges: "during a bronchoscopy, a foreign object was found in the right main bronchus and removed.The foreign object is a part of the suction port of the artificial nose - more precisely, the closing membrane." it was reported "the patient didn't suffer any damage." customer reports patient condition as "fine".

Manufacturer Narrative

(b)(4).The customer returned the actual sample along with 2 representative samples.A visual exam was performed and it was observed that only part of the actual sample was returned.No issues were found with the representative samples.In the current manufacturing procedure, 1oo% occlusion testing and a visual inspection after the assembly process are conducted.Thus, any ineffective products will be culled out during this process.Operators who conduct the inspection will reject the product if there is any defective product.Therefore, it is very unlikely for the closing membrane to be detached from the product.The reported complaint could not be confirmed as the complete sample was not returned for evaluation.

• Brand Name: HUDSON TRACH-VENT+,CLEAN
• Type of Device: CONDENSER, HEAT AND MOISTURE
• Manufacturer (Section D): TELEFLEX MEDICAL; perak, west malaysia
• MDR Report Key: 7156607
• MDR Text Key: 96231887
• Report Number: 8040412-2018-00002
• Device Sequence Number: 1
• Product Code: BYD
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• 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: 41312
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2018
• Initial Date Manufacturer Received: 12/11/2017
• Initial Date FDA Received: 01/02/2018
• Supplement Dates Manufacturer Received: 01/23/2018
• Supplement Dates FDA Received: 01/29/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1