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

Catalog Number 1886

Device Problem Human-Device Interface Problem (2949)

Patient Problem Laceration(s) (1946)

Event Date 02/05/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).An injury was reported.However the extent of the injury, and any necessary medical intervention was not reported.Teleflex has requested this information from the customer.A visual, dimensional, and functional inspection of the device involved in the complaint could not be conducted since the device or a picture of the alleged defect was not provided at the time of this report.However material from the production line was verified and no issues were found that can lead this customer complaint.A device history record review could not be conducted since the lot number was not provided.Customer complaint cannot be confirmed based only on the information provided.In order to perform a proper and thorough investigation to confirm the complaint and determine a root cause, it is necessary to evaluate the sample involved.If the sample becomes available this investigation will be updated with the evaluation results.

Event Description

Customer complaint alleges "during usage of the nebulizer mask, a patient child has tried to pull off the mask and end up with a cut on the finger due to the metal piece on the mask".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; research triangle park NC
• Manufacturer (Section G): TELEFLEX MEDICAL; parque industrial finsa; nuevo laredo 88275 ; MX 88275
• Manufacturer Contact: linda woodall ; 3015 carrington mill blvd; morrisville 27560 ; 9196942566
• MDR Report Key: 7273889
• MDR Text Key: 100434681
• Report Number: 3004365956-2018-00051
• Device Sequence Number: 1
• Product Code: CAF
• Combination Product (y/n): N
• Reporter Country Code: SN
• PMA/PMN Number: K930525
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/06/2018

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 Catalogue Number: 1886
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/06/2018
• Initial Date FDA Received: 02/15/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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