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

Catalog Number 1883

Device Problem Failure to Deliver (2338)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/10/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device involved in this complaint has been received by the manufacturer.However, the investigation of said device in progress at the time of this report.A follow up report will be submitted at the conclusion of the device investigation.

Event Description

Customer complaint alleges "neb was not aerosolizing the medication." alleged issue reported as occurring during use.Customer reports no injury to the patient.Patient condition reported as "stable".

Manufacturer Narrative

(b)(4).The sample was returned for evaluation.A visual exam was performed and no defects were observed.The sample was functionally tested and 5cc of water was added to the returned nebulizer unit and the tubing was connected to an air flowmeter.The pressure was increased to 8 lpm.A mist was produced from the chamber of the nebulizer.Based on the investigation performed, the reported complaint could not be confirmed.Functional inspection of the unit indicated that a mist was produced with no issues.

Event Description

Customer complaint allges "neb was not aerosolizing the medication." alleged issue reported as occurring during use.Customer reports no injury to the patient.Patient condition reported as "stable".

• Brand Name: HUDSON MICRO MIST NEBULIZER W/TEE,TBG & MTHPC
• 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: 7147445
• MDR Text Key: 95846912
• Report Number: 3004365956-2017-00475
• 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: health professional,user faci
• Reporter Occupation: Emergency Medical Technician
• Type of Report: Initial,Followup
• Report Date: 12/14/2017

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: 1883
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/14/2017
• Initial Date FDA Received: 12/27/2017
• Supplement Dates Manufacturer Received: 01/04/2018
• Supplement Dates FDA Received: 02/05/2018
• Was Device Evaluated by Manufacturer?: Yes
• 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