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

Catalog Number 2412-11

Device Problem Material Separation (1562)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/27/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Additional information regarding patient impact has been requested by teleflex.No response has been received to date from the customer.

Event Description

Customer complaint alleges "during a hi flo theory, the glue that connects the tubing to the nasal cannulas came undone and patient stopped receiving oxygen flo".No patient impact or consequence was reported.

Event Description

Customer complaint alleges "during a hi flo theory, the glue that connects the tubing to the nasal cannulas came undone and patient stopped receiving oxygen flo".No patient impact or consequence was reported.

Manufacturer Narrative

(b)(4).The actual sample involved in the reported complaint was not returned for evaluation; therefore, 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.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.Complaint verification testing could not be performed as the actual sample was not returned for analysis.A device history record review was performed and no relevant findings were identified.Without the device to evaluate the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.

• 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
• MDR Report Key: 8033860
• MDR Text Key: 126224166
• Report Number: 8040412-2018-00290
• 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,health
• Type of Report: Initial,Followup
• Report Date: 10/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 2412-11
• Device Lot Number: 201714
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 12/21/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NONE REPORTED.; NONE REPORTED.