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

Catalog Number 1884

Device Problem Failure to Deliver (2338)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/10/2020

Event Type  malfunction  

Manufacturer Narrative

Qn#: (b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.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 "on (b)(6) 2020, the nurse gave the patient oxygen atomization inhalation and used a disposable nebulizer.It was found that the nebulizer did not mist and replaced new one, the mist is normal.No effect on patient." no patient harm reported.

• Brand Name: HUDSON MICRO MIST NEBULIZER W/TEE
• Type of Device: NEBULIZER (DIRECT PATIENT INTE
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• Manufacturer (Section G): TELEFLEX MEDICAL; parque industrial finsa; nuevo laredo 88275 ; MX 88275
• Manufacturer Contact: victoria sandlin ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 10843690
• MDR Text Key: 216366528
• Report Number: 3004365956-2020-00230
• Device Sequence Number: 1
• Product Code: CAF
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K930525
• 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: 10/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 1884
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 10/26/2020
• 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: NONE REPORTED.