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

Catalog Number 1883

Device Problem Obstruction of Flow (2423)

Patient Problem No Patient Involvement (2645)

Event Date 02/03/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.Material from the production line was verified and no issues were found.Without the device to evaluate, the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.If the sample becomes available at a later date a follow up report will be submitted with investigation results.

Event Description

Complaint reported as: "it was reported that "drugs are not sprayed properly, assumed to be blocked in nozzle." no patient involvement reported.

Manufacturer Narrative

(b)(4).The sample was returned for evaluation.A visual exam was performed and no defects or anomalies were identified.Functional testing was performed and 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 functional testing, mist was not produced.A device history record review was performed and no relevant findings were identified.The reported complaint that the nebulizer did not produce mist was confirmed during the functional inspection.The sample will be forwarded to the manufacturing site to perform further investigation to determine a root cause for the reported issue.

Event Description

Complaint reported as: "it was reported that "drugs are not sprayed properly, assumed to be blocked in nozzle." no patient involvement reported.

• 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: 9750580
• MDR Text Key: 191573062
• Report Number: 3004365956-2020-00051
• 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: 02/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/25/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 1883
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/28/2020
• Date Manufacturer Received: 03/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1