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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON MICRO MIST NEBULIZER W/ELONG; NEBULIZER (DIRECT PATIENT INTE
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TELEFLEX MEDICAL HUDSON MICRO MIST NEBULIZER W/ELONG; NEBULIZER (DIRECT PATIENT INTE Back to Search Results
Catalog Number 1886
Device Problem Material Rupture (1546)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/27/2020
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 in the complaint was performed on a picture provided by the customer of product code 1886 (micro mist nebulizer w/elong.The issue as described "when the doctor was performing aerosol treatment on the patient, the tube suddenly burst at the connection between the small-capacity nebulizer and the compressor", was observed in the customer complaint pictures provided.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 "when the doctor was performing aerosol treatment on the patient, the tube suddenly burst at the connection between the small-capacity nebulizer and the compressor and replaced a new one,no impact on the patient".No patient injury reported.Patient condition reported as "fine".
 
Event Description
It was reported that "when the doctor was performing aerosol treatment on the patient, the tube suddenly burst at the connection between the small-capacity nebulizer and the compressor and replaced a new one,no impact on the patient".No patient injury reported.Patient condition reported as "fine".
 
Manufacturer Narrative
Qn#(b)(4).The customer returned tubing from catalog number 1886 (micro mist nebulizer w/elong), batch 74e1902914 for analysis.During the visual inspection, it was observed that the received sample had ruptured.A dimensional inspection test was performed on the wall thickness of the tubing and no dimensional issues were found.As an additional test, the affected part of the tubing was cut and a new connector was installed on the tubing to perform functional testing to identify any possible issues with the oxygen tubing.During this test no similar issues were identified.The device history record of batch number 74e1902914 that belongs to catalog number 1886 (micro mist nebulizer w/elong) 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.The complaint was confirmed based on the visual inspection.Although the complaint was confirmed, a root cause for the issue could not be identified.Teleflex will continue to monitor and trend complaints of this nature.
 
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Brand Name
HUDSON MICRO MIST NEBULIZER W/ELONG
Type of Device
NEBULIZER (DIRECT PATIENT INTE
Manufacturer (Section D)
TELEFLEX MEDICAL
morrisville NC
MDR Report Key11202852
MDR Text Key227804434
Report Number3004365956-2021-00005
Device Sequence Number1
Product Code CAF
Combination Product (y/n)N
PMA/PMN Number
K930525
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 12/29/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/20/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number1886
Device Lot Number74E1902914
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/20/2021
Date Manufacturer Received02/22/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
N/A.
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