MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON NEBULIZER,LARGE VOLUME,VAR CONCENTRATIO; NEBULIZER (DIRECT PATIENT INTE

Catalog Number 1770

Device Problem Failure to Deliver (2338)

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

Event Date 12/12/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

User reported the device works briefly for a week or two, then stops putting out mist.Alleged defect detected during home use.There was no report of patient harm.

Manufacturer Narrative

Qn# (b)(4).The customer returned one sealed representative sample of catalog number 1770 nebulizer, large volume, var concentration which consisted of a jar, pickup tube, outlet, entrainment collar, wing nut and an ifu.The sample was returned in a sealed bag.During the visual inspection, no defects or anomalies were identified.A functional inspection was performed and the wing nut was connected to the oxygen flowmeter.Per the ifu, sterile water was poured into the jar.The entrainment collar was set at 5 lpm, 8 lpm and 10 lpm and the oxygen flowmeter was respectively set at 5 lpm, 8 lpm and 10 lpm.The pressure was increased to 50 psi.During the functional testing, mist was produced from the chamber of the nebulizer.A faint mist was produced at 5 lpm and more visible mist was produced at 8 lpm and 10 lpm.The device history record of batch number 74e1900972 that belongs to catalog number 1770 has been reviewed and no issues or discrepancies were found which could potentially be related to this complaint.No non-conformance reports were originated for the lot in question that can be associated to the complaint reported.The dhr shows that the product was assembled and inspected according to specifications.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 mist at each setting.An actual sample was not returned for investigation; therefore, the root cause of this investigation is undetermined.

Event Description

User reported the device works briefly for a week or two, then stops putting out mist.Alleged defect detected during home use.There was no report of patient harm.

• Brand Name: HUDSON NEBULIZER,LARGE VOLUME,VAR CONCENTRATIO
• Type of Device: NEBULIZER (DIRECT PATIENT INTE
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• MDR Report Key: 9544936
• MDR Text Key: 193614474
• Report Number: 3004365956-2020-00005
• Device Sequence Number: 1
• Product Code: CAF
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup
• Report Date: 12/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 1770
• Device Lot Number: PN042779
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/23/2019
• Date Manufacturer Received: 01/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NONE REPORTED; NONE REPORTED