MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON NEB-U-MIST,UP-DRAFT W/1083,INTL; NEBULIZER (DIRECT PATIENT INTE

Catalog Number 41710

Device Problem Burst Container or Vessel (1074)

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

Event Date 05/01/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).No sample was returned; however, the customer did provide a photo for evaluation.It was observed on the photo that the tubing ruptured as described in the complaint.There is not sufficient evidence to assure this issue was originated during the manufacturing process.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.If the sample becomes available at a later date a follow up report will be submitted with investigation results.

Event Description

It was reported that: "the mask got hotter and hotter and cracked after 5 minutes." additional information has been requested regarding patient use.It is unknown at this time if the event occurred prior to use or during use on a patient.The issue was reported by a distributor in (b)(6).

• Brand Name: HUDSON NEB-U-MIST,UP-DRAFT W/1083,INTL
• Type of Device: NEBULIZER (DIRECT PATIENT INTE
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC
• Manufacturer (Section G): TELEFLEX MEDICAL; parque industrial finsa; nuevo laredo 88275 ; MX 88275
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9194334854
• MDR Report Key: 8697345
• MDR Text Key: 148008475
• Report Number: 3004365956-2019-00161
• Device Sequence Number: 1
• Product Code: CAF
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K760489
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/24/2019

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: No Information
• Device Catalogue Number: 41710
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 05/24/2019
• Initial Date FDA Received: 06/13/2019
• 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