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

Catalog Number 1886

Device Problem Failure to Deliver (2338)

Patient Problem No Patient Involvement (2645)

Event Date 06/14/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that "(b)(6) 2019, (b)(6) hospital, doctor found no mist came out from thr nebulizer".No patient injury reported.

Manufacturer Narrative

(b)(4).The customer returned one assembled unit of catalog number 1886 micro mist nebulizer w/elong for analysis, lot 74e1801184.A visual inspection was performed and no defects or anomalies were observed.5cc of water was added to the returned nebulizer unit, the tubing was connected to an air flowmeter and the pressure was increased to 8 lpm.During the functional inspection, the nebulizer produced mist and bubbles were not produced.The device history record of batch number 74e1801184 that belongs to catalog number 1886 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 our specifications.The reported complaint that the nebulizer did not produce mist was not confirmed through functional inspection.There were no issues found with the returned sample.

Event Description

It was reported that "(b)(6) 2019, guangzhou women and children's hospital, doctor found no mist came out from thr nebulizer".No patient injury reported.

• Brand Name: HUDSON MICRO MIST NEBULIZER W/ELONG
• Type of Device: NEBULIZER (DIRECT PATIENT INTE
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC
• MDR Report Key: 8789657
• MDR Text Key: 151003353
• Report Number: 3004365956-2019-00194
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 06/19/2019

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 Expiration Date: 05/14/2023
• Device Catalogue Number: 1886
• Device Lot Number: 74E1801184
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/08/2019
• Initial Date Manufacturer Received: 06/19/2019
• Initial Date FDA Received: 07/15/2019
• Supplement Dates Manufacturer Received: 07/23/2019
• Supplement Dates FDA Received: 08/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NOT REPORTED; NOT REPORTED; NOT REPORTED