MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON TRACH ADAPTOR; CONNECTOR, AIRWAY (EXTENSION)

Catalog Number 2415-01

Device Problem Hole In Material (1293)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/20/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The investigation into this complaint is still in progress.

Event Description

Customer complaint alleges "tubing on the cannula has holes." alleged defect detected during use.No harm or injury to the patient.Patient condition reported as "fine.".

Manufacturer Narrative

(b)(4).The actual sample involved in the reported complaint was not returned for evaluation; therefore, the complaint could not be confirmed.In the current manufacturing procedure 100% leak testing is conducted at the assembly area; therefore, any defects would be detected prior to release from the manufacturing facility.As the actual sample was not returned, ten samples of the same catalog number were selected from current production at the manufacturing facility.A visual exam was performed and no defects were observed.In addition, the samples were leak tested and no issues were detected.It is possible that this defect occurred due to mishandling of the product.The failure was reported during use on a patient.The tube must be soft and flexible in order to meet the hfnc oxygen therapy and user requirement; thus it is prone to tears and pin holes when it is over pulled and stretched.The instructions for use (ifu) mentions that the tubing should not be stretched to remove condensation, or damage/malfunction may occur.

Event Description

Customer complaint alleges "tubing on the cannula has holes." alleged defect detected during use.No harm or injury to the patient.Patient condition reported as "fine".

• Brand Name: HUDSON TRACH ADAPTOR
• Type of Device: CONNECTOR, AIRWAY (EXTENSION)
• 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: 6229380
• MDR Text Key: 64065965
• Report Number: 8040412-2017-00019
• Device Sequence Number: 1
• Product Code: BZA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Respiratory Therapist
• Type of Report: Initial,Followup
• Report Date: 12/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 2415-01
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/16/2017
• 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