MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON UP-DRAFT II OPTI-NEB NEBULIZER W/RESERV; NEBULIZER (DIRECT PATIENT INTE

Model Number IPN049797

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/22/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.A visual inspection of the product involved was performed on two pictures provided by the customer.The issue reported "broken - other" was observed on the steam area of the nebulizer jar p/n 12152.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

It was reported "(b)(6) female patient.The connector between the reservoir and the tubing broke.The nurse of the homecare patient reported that the consequence is a leak at the level of this reservoir.This patient has 4 sessions of nebulizer a day and she is tracheostomized and ventilated 24/7".No patient injury, harm, or desaturation reported.Patient condition reported as "fine".Connector was replaced.

Event Description

It was reported "52 year-old female patient.The connector between the reservoir and the tubing broke.The nurse of the homecare patient reported that the consequence is a leak at the level of this reservoir.This patient has 4 sessions of nebulizer a day and she is tracheostomized and ventilated 24/7".No patient injury, harm, or desaturation reported.Patient condition reported as "fine".Connector was replaced.

Manufacturer Narrative

Qn# (b)(4).The customer returned one reservoir jar and tubing from 1734 up-draft ii opti-neb nebulizer w/reservoir for investigation.The returned sample was visually examined with and without magnification.Visual examination of the returned sample revealed the reservoir inlet appears to have broken off into the air supply tubing.The customer also provided photos that also show the reservoir inlet broke off into the tubing.Functional testing could not be performed as the complete sample was not returned.Based on the visual exam the complaint was confirmed; however, there is not sufficient evidence to assure this damage was originated during the manufacturing process.The manufacturing site reports that material from the production line was verified and no issues were found that can lead to this customer complaint.The root cause for the condition reported could not be identified.

• Brand Name: HUDSON UP-DRAFT II OPTI-NEB NEBULIZER W/RESERV
• Type of Device: NEBULIZER (DIRECT PATIENT INTE
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• MDR Report Key: 11591953
• MDR Text Key: 243128982
• Report Number: 3004365956-2021-00106
• Device Sequence Number: 1
• Product Code: CAF
• UDI-Device Identifier: 14026704645838
• UDI-Public: 14026704645838
• Combination Product (y/n): N
• PMA/PMN Number: K760489
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 03/11/2021

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: 07/28/2022
• Device Model Number: IPN049797
• Device Catalogue Number: 1734
• Device Lot Number: 74G1702961
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/30/2021
• Initial Date Manufacturer Received: 03/11/2021
• Initial Date FDA Received: 03/30/2021
• Supplement Dates Manufacturer Received: 05/04/2021
• Supplement Dates FDA Received: 05/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1