MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON MICRO MIST NEB W/ELONG ADULT MASK,TBG &; NEBULIZER (DIRECT PATIENT INTE

Catalog Number 1945

Device Problem Gas/Air Leak (2946)

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

Event Date 08/16/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device involved has not been received by the manufacturer at the time of this report.The device history record (dhr) has been reviewed and no issues or discrepancies were found which could potentially be related to this complaint.The dhr shows that the product was assembled and inspected according to our specifications.Customer complaint cannot be confirmed based only on the information provided.To perform an investigation and determine the source of defect reported it is necessary to evaluate the sample involved in this complaint.If the sample becomes available this report will be updated with the evaluation results.

Event Description

Customer complaint alleges "the micro mist presented an oxygen leak." alleged issue reported as found during patient use.No patient impact or consequence was reported.

Event Description

Customer complaint alleges "the micro mist presented an oxygen leak." alleged issue reported as found during patient use.No patient impact or consequence was reported.

Manufacturer Narrative

(b)(4).The sample was returned for evaluation.A visual exam was performed and it was found that there was residue on the jet , jar, and cap.A functional inspection was also performed and the returned sample was connected to a flowmeter and the airflow was increased to 8 lpm.No leaks were detected from the nebulizer.Based on the investigation performed, the reported complaint could not be confirmed.There were no issues found with the returned device.

• Brand Name: HUDSON MICRO MIST NEB W/ELONG ADULT MASK,TBG &
• Type of Device: NEBULIZER (DIRECT PATIENT INTE
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC
• MDR Report Key: 7851739
• MDR Text Key: 119496790
• Report Number: 3004365956-2018-00265
• 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: distributor,foreign,user faci
• Type of Report: Initial,Followup
• Report Date: 08/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/06/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 11/01/2022
• Device Catalogue Number: 1945
• Device Lot Number: 74L1700522
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/05/2018
• Date Manufacturer Received: 09/25/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NONE REPORTED.; NONE REPORTED.