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 Known Impact Or Consequence To Patient (2692)

Event Date 03/16/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The actual device involved in this complaint has not been received by the manufacturer at the time of this report.A visual inspection was performed on a picture provided by the customer of product code 1886 (micro mist nebulizer w/elong) and no issues were found that can lead this customer complaint.The device history record (dhr) has been reviewed and no issues or discrepancies were found which could potentially be related to this complaint.Dhr shows that the product was assembled and inspected according to our specifications.To perform a proper and thorough investigation, it is necessary to evaluate the sample involved on this complaint.Customer complaint cannot be confirmed based only on the information provided.Root cause is unknown.No corrective actions can be assigned.If the sample becomes available this report will be updated with the evaluation results.

Event Description

Customer complaint alleges "doctor in respiratory dept found no mist came out from the small volume nebulizer during test prior to use on patient".There was no report of patient impact or consequence.

Event Description

Customer complaint alleges "doctor in respiratory dept found no mist came out from the small volume nebulizer during test prior to use on patient".There was no report of patient impact or consequence.

Manufacturer Narrative

Qn#(b)(4).The sample was returned for evaluation.A visual exam was performed and no defects were observed.Functional testing was also performed and no issues were detected.The sample was found to be within specification.Based on the investigation performed, the complaint could not be confirmed.There were no issues found with the returned device.

• 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: 7451529
• MDR Text Key: 106205520
• Report Number: 3004365956-2018-00124
• 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: 04/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/07/2022
• Device Catalogue Number: 1886
• Device Lot Number: 74J1701169
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/25/2018
• Date Manufacturer Received: 07/19/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1