MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON MICRO MIST NEBULIZER W/ELONG

Catalog Number 1886

Device Problems Disconnection (1171); Occlusion Within Device (1423)

Patient Problem No Patient Involvement (2645)

Event Date 06/24/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).One (1) unit of catalog number 1886, micro mist nebulizer w/elong, lot 02j1102603 was received for analysis.Visual inspection of the returned nebulizer assembly indicated no defects or anomalies.Visual inspection of the returned nebulizer adaptor with chamber obstructed and tubing disconnected was not confirmed through visual inspection.The unit was connected to a flowmeter and the airflow was increased to 8 lpm and 10 lpm).During the functional inspection, mist was produced and there were no issues with the tubing disconnecting from the nebulizer.The customer's complaint was not confirmed.The device history record of lot #02j1102603 that belongs to catalog number 1886 has been reviewed and no issues or discrepancies were found which could potentially be related to this complaint.Records reviewed showed that there were no issues related to functional issues on the molded component involved in this complaint.No corrective action is needed at this time as the root cause for this complaint investigation could not be determined.The investigation found no evidence to suggest a manufacturing related cause, therefore, the root cause is undetermined.

Event Description

The customer alleges that the nebulizer chamber appeared to be obstructed and the tubing disconnected.

• Brand Name: HUDSON MICRO MIST NEBULIZER W/ELONG
• Type of Device: NEBULIZER
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC
• Manufacturer (Section G): TELEFLEX MEDICAL; parque industrial finsa; nuevo laredo 88275 ; MX 88275
• Manufacturer Contact: margie burton, rn ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9194334965
• MDR Report Key: 5117604
• MDR Text Key: 27248402
• Report Number: 3004365956-2015-00297
• Device Sequence Number: 1
• Product Code: CAF
• Combination Product (y/n): N
• Reporter Country Code: NZ
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Other Health Care Professional
• Report Date: 09/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/01/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 1886
• Device Lot Number: 02J1102603
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/22/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/16/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/22/2011
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1