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

Catalog Number 2412-11

Device Problem Split (2537)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/31/2017

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 rn taking care of the patient called the rt to tell them that there was something wrong with the cannula and that the patient was desaturating.At her arrival she noticed that there was a piece of tape on the corrugated tubing portion and when she removed it, she noticed that the tubing was split open and being held by the tape.A new one was replaced on the patient and there were no negative outcomes to the patient.".

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 the corrugated tubing was split.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 "the rn taking care of the patient called the rt to tell them that there was something wrong with the cannula and that the patient was desaturating.At her arrival she noticed that there was a piece of tape on the corrugated tubing portion and when she removed it, she noticed that the tubing was split open and being held by the tape.A new one was replaced on the patient and there were no negative outcomes to the patient.".

• Brand Name: HUDSON COMFORT FLO PLUS CANNULA W/CHIN STRAP-L
• 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: 7027274
• MDR Text Key: 92879082
• Report Number: 8040412-2017-00236
• 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: 10/31/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 2412-11
• Device Lot Number: 201631
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/29/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/22/2017
• 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