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

Catalog Number 2412-12

Device Problem Material Separation (1562)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/14/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

Complaint reported as: customer claimed that the tubing on the cannula ripped where it meets the nose piece of the cannula.No patient injury or consequence reported.Patient condition reported as "fine".

Event Description

Complaint reported as: customer claimed that the tubing on the cannula ripped where it meets the nose piece of the cannula.No patient injury or consequence reported.Patient condition reported as "fine".

Manufacturer Narrative

(b)(6).The actual sample involved in the reported complaint was not returned for evaluation; therefore, the complaint could not be confirmed.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.

• Brand Name: HUDSON COMFORT FLO PLUS CANNULA W/CHIN STRAP-M
• Type of Device: CANNULA, NASAL, OXYGEN
• Manufacturer (Section D): TELEFLEX MEDICAL SDN. BHD.; perak, west malaysia
• MDR Report Key: 9432561
• MDR Text Key: 183741002
• Report Number: 8040412-2019-00340
• Device Sequence Number: 1
• Product Code: CAT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 11/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 2412-12
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NONE REPORTED.; NONE REPORTED.