MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON COMFORT FLO PLUS CANNULA W/CHIN STRAP-M; CANNULA, NASAL, OXYGEN

Catalog Number 2412-12

Device Problems Hole In Material (1293); Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/23/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Customer complaint alleges that the respiratory therapist found holes in the circuit after noticing a fine mist escaping out of a portion of the tubing.The circuit was replaced.Alleged defect detected during use.No reported harm to the patient.Patient condition reported as "fine".

Manufacturer Narrative

(b)(4).A device history record (dhr) review could not be performed as the lot number was unknown.The sample was returned for evaluation.A visual exam was performed and it was observed that there were tears in the tubing.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.In the current manufacturing procedure, 100% leak testing is conducted during the assembly process and 100% visual inspection is done at the packing area.Any defective products would be detected prior to release from the manufacturing facility.

Event Description

Customer complaint alleges that the respiratory therapist found holes in the circuit after noticing a fine mist escaping out of a portion of the tubing.The circuit was replaced.Alleged defect detected during use.No reported harm to the patient.Patient condition reported as "fine".

• Brand Name: HUDSON COMFORT FLO PLUS CANNULA W/CHIN STRAP-M
• Type of Device: CANNULA, NASAL, OXYGEN
• 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: 6407334
• MDR Text Key: 70073905
• Report Number: 8040412-2017-00057
• Device Sequence Number: 1
• Product Code: CAT
• 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: 02/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 2412-12
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/17/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/18/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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