MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON MICRO MIST NEBULIZER W/ELONG; NEBULIZER (DIRECT PATIENT INTE

Model Number IPN049807

Device Problem Material Rupture (1546)

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

Event Date 04/14/2021

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

It was reported that "the tube was burst when using on patient.Then changed new one,no impact on patient".No patient injury or harm reported.Patient condition reported as "fine".

Manufacturer Narrative

Qn #(b)(4).The customer reported the tubing burst during use.The customer returned one nebulizer kit which includes a jet, jar, cap, tubing, and mask.The returned sample was visually examined with and without magnification.Visual examination of the returned tubing revealed the tubing had burst.No other defects or anomalies were observed.A dimensional inspection test was performed on the wall thickness of the tubing, and no dimensional issues were found.The affected part of the tubing was cut and a new connector was installed on the tubing in order to perform functional testing.No issues were encountered and no leaks were found.The tubing is designed to allow oxygen flow even when there is an obstruction in the tubing.Based on the visual exam, the reported complaint was confirmed.Although the complaint was confirmed, a root cause for the issue could not be identified.There was no evidence to suggest a manufacturing related issue.

Event Description

It was reported that "the tube was burst when using on patient.Then changed new one,no impact on patient".No patient injury or harm reported.Patient condition reported as "fine".

• Brand Name: HUDSON MICRO MIST NEBULIZER W/ELONG
• Type of Device: NEBULIZER (DIRECT PATIENT INTE
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• MDR Report Key: 11783242
• MDR Text Key: 249285465
• Report Number: 3004365956-2021-00177
• Device Sequence Number: 1
• Product Code: CAF
• UDI-Device Identifier: 14026704645920
• UDI-Public: 14026704645920
• 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: 04/20/2021

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: No Information
• Device Model Number: IPN049807
• Device Catalogue Number: 1885
• Device Lot Number: 74L1902182
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/06/2021
• Initial Date Manufacturer Received: 04/20/2021
• Initial Date FDA Received: 05/06/2021
• Supplement Dates Manufacturer Received: 06/17/2021
• Supplement Dates FDA Received: 06/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1