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 08/06/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device involved was not returned to the manufacturer for evaluation.However material from the production line was verified and no issues were found that can lead this customer complaint.The device history record of the batch number reported has been reviewed, and no issues or discrepancies were found which could potentially be related to this complaint.Customer complaint cannot be confirmed based only on the information provided.To perform a proper investigation and determine the source of defect reported it is necessary to evaluate the sample involved in this complaint.If the sample becomes available this report will be updated with the evaluation results.Teleflex will continue to monitor customer feedback for complaints of this nature.

Event Description

Customer complaint alleges the tubing disconnects from the mask during use.No patient injury or consequence reported.Patient condition reported as "fine".

• 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: 7818397
• MDR Text Key: 118303031
• Report Number: 3004365956-2018-00250
• 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,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/27/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 1041
• Device Lot Number: 74D1802170
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/15/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/20/2018
• 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: NONE REPORTED.