MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON MICRO MIST NEBULIZER W/ELONG; NEBULIZER (DIRECT PATIENT INTE

Catalog Number 1885

Device Problem Overheating of Device (1437)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/01/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Date of this report: 04/16/2019.Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review could not be performed as the lot number reported by the customer is not valid.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

The complaint is reported as: "nebulizer gets hot and makes a lot of noise and causes tubing to get hot." no report of patient injury.Patient condition was reported as fine.

• Brand Name: HUDSON MICRO MIST NEBULIZER W/ELONG
• 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: 8592063
• MDR Text Key: 144454651
• Report Number: 3004365956-2019-00108
• Device Sequence Number: 1
• Product Code: CAF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K930525
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Other
• Type of Report: Initial

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: Lay User/Patient
• Device Catalogue Number: 1885
• Device Lot Number: 74H1802101
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/08/2019
• 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
• Treatment: NOT REPORTED