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

Catalog Number 1883

Device Problem Failure to Deliver (2338)

Patient Problem No Patient Involvement (2645)

Event Date 03/27/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed and no relevant findings were identified.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

Customer complaint alleges "tried to connect and use the nebulizer, but the product doesn't spray at all" during pre-test.No patient involvement reported.

Manufacturer Narrative

Qn#(b)(4).The customer returned a jet, jar, cap, tubing, corrugated tubing, mouthpiece and tee-connector from catalog number 1883 micro mist nebulizer.During the visual inspection the tubing and connectors were found to be different from components of the finished good 1883.The shape and size of the reduced nose hoses were longer and made of a shiny plastic material.No other issues were observed.The sample was functionally tested and no issues were found than can lead to the condition reported by the customer.The received sample is within specification.The device history record of batch number 74k1701030 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.Based on the investigation performed, the reported complaint could not be confirmed.There were no issues found with the returned sample.The device functioned as intended.

Event Description

Customer complaint alleges "tried to connect and use the nebulizer, but the product doesn't spray at all" during pre-test.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: 10008085
• MDR Text Key: 190138531
• Report Number: 3004365956-2020-00101
• 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: 04/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2020
• 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: 74K1701030
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/06/2020
• Date Manufacturer Received: 06/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NONE REPORTED.; NONE REPORTED.