MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON MASK,MEDIUM CONC,ELONG,ADULT; MASK, OXYGEN

Catalog Number 1041

Device Problem Disconnection (1171)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/08/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A visual, dimensional, and functional inspection of the device involved in this complaint could not be conducted since the device was not returned.No photo of the alleged defect was provided.A device history record review could not be conducted since the lot number provided "h88010410" is not a valid lot number.However material from the production line was inspected and no issues were detected related to this customer complaint.Customer complaint cannot be confirmed based only on the information provided.In order to perform proper investigation and determine the source of the alleged defect reported it is necessary to evaluate the sample involved on this complaint.If the device sample becomes available at a later date this complaint will be updated accordingly.

Event Description

Customer complaint alleges "the hose disconnected from the mask during use on a patient".There was no report of harm to the patient.

• Brand Name: HUDSON MASK,MEDIUM CONC,ELONG,ADULT
• Type of Device: MASK, OXYGEN
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC
• Manufacturer (Section G): TELEFLEX MEDICAL; parque industrial finsa; nuevo laredo 88275 ; MX 88275
• Manufacturer Contact: linda woodall ; 3015 carrington mill blvd; morrisville 27560 ; 9196942566
• MDR Report Key: 6253251
• MDR Text Key: 64893788
• Report Number: 3004365956-2017-00045
• Device Sequence Number: 1
• Product Code: BYG
• 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,user f
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/20/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/16/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 1041
• Device Lot Number: H88010410
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/20/2016
• 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
• Treatment: "HOSE"