MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON MASK,NON-REBREATH W/SAFETY VENT,ELONGAT; MASK, OXYGEN, NON-REBREATHING

Catalog Number 1059

Device Problem Burst Container or Vessel (1074)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/19/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device involved was not returned by the customer for evaluation by the manufacturer.A picture was submitted by the customer with the complaint, however this picture is not clear enough in order to confirm this customer complaint.The device history record (dhr) of 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 alleged defect reported, it is necessary to evaluate the sample involved.Root cause cannot be determined.No corrective actions can be assigned.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 during use on a patient the bag component "burst".No patient harm was reported.Patient condition reported as fine.(cont.) it was reported "the doctor secured the bag with a knot so that oxygenation of the patient could continue.".

• Brand Name: HUDSON MASK,NON-REBREATH W/SAFETY VENT,ELONGAT
• Type of Device: MASK, OXYGEN, NON-REBREATHING
• 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: 8159799
• MDR Text Key: 130329586
• Report Number: 3004365956-2018-00360
• Device Sequence Number: 1
• Product Code: KGB
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 1059
• Device Lot Number: 74H1700882
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/28/2018
• Initial Date FDA Received: 12/13/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/07/2017
• 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