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

Catalog Number 1883

Device Problem Infusion or Flow Problem (2964)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/22/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

Customer reported the device did not nebulize all the medication.It was reported 1-1.5ml remained in the cup after completion of therapy.No medical intervention was required.Patient was reported to be "fine".

Manufacturer Narrative

Qn#: (b)(4).The customer returned one sealed representative unit of catalog number 1883 micro mist nebulizer w/tee, tubing & mouthpiece (batch 74k1901707) which consisted of a jet, jar, cap, tubing, mouthpiece, tee connector, corrugated tube and an ifu.All the components were visually inspected; no defects or anomalies were found.A functional inspection was performed to determine if the nebulizer produced mist.The tubing was used to connect the nebulizer unit to the air flowmeter.6cc 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.During the functional testing, a mist was produced from the chamber of the nebulizer and no water was left in the jar after nebulizing for approximately 6 minutes.Therefore, based on the functional inspection , no functional issues were found with the returned sample.A device history record review was performed and no relevant findings were identified.The reported complaint that the nebulizer did not produce mist was not confirmed during the functional inspection.During the functional inspection, the returned nebulizer produced a strong mist.However , because the actual sample was not returned, the root cause of this investigation is undetermined.

Event Description

Customer reported the device did not nebulize all the medication.It was reported 1-1.5ml remained in the cup after completion of therapy.No medical intervention was required.Patient was reported to be "fine".

• Brand Name: HUDSON MICRO MIST NEBULIZER W/TEE,TBG & MTHPC
• Type of Device: NEBULIZER (DIRECT PATIENT INTE
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• MDR Report Key: 9712932
• MDR Text Key: 196753282
• Report Number: 3004365956-2020-00048
• Device Sequence Number: 1
• Product Code: CAF
• Combination Product (y/n): N
• PMA/PMN Number: K930525
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 01/29/2020

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: 1883
• Device Lot Number: 74K1901707
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/10/2020
• Initial Date Manufacturer Received: 01/29/2020
• Initial Date FDA Received: 02/14/2020
• Supplement Dates Manufacturer Received: 02/26/2020
• Supplement Dates FDA Received: 02/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NONE REPORTED.; NONE REPORTED.