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

Catalog Number 1881

Device Problem Failure to Deliver (2338)

Patient Problem No Patient Involvement (2645)

Event Date 01/21/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).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.The device history record (dhr) has been reviewed and no issues or discrepancies were found which could potentially be related to this complaint.Dhr shows that the product was assembled and inspected according to our specifications.Customer complaint cannot be confirmed based only on the information provided.To perform a proper and thorough investigation to confirm the alleged defect and determine a root cause, it is necessary to evaluate the sample involved in this complaint.If the sample becomes available at a later date, this report will be updated with the evaluation results.

Event Description

Customer complaint alleges "that medication could not be sprayed out from the nebulizer during pretest.As a result, it was replaced by a new one." it was reported there was no patient involvement.

Manufacturer Narrative

(b)(4).The customer returned a jet, jar, cap, mouthpiece, t-connector, and packaging label for investigation.A visual exam was performed and no defects were observed.Functional testing was also performed and lab inventory tubing was used to connect the nebulizer unit to the air flowmeter.5 cc of water was added to the returned nebulizer unit and lab inventory tubing was connected to an air flowmeter and the pressure was increased to 8 lpm.Mist was produced during the functional testing.Based on the investigation performed, the reported complaint could not be confirmed.There were no issues found with the returned sample.The sample functioned as intended.

Event Description

Customer complaint alleges "that medication could not be sprayed out from the nebulizer during pretest.As a result, it was replaced by a new one." it was reported there was no patient involvement.

• Brand Name: HUDSON MICRO MIST NEBULIZER W/TEE
• 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: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9194334854
• MDR Report Key: 7377465
• MDR Text Key: 103691868
• Report Number: 3004365956-2018-00099
• Device Sequence Number: 1
• Product Code: CAF
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K930525
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/19/2018

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: 1881
• Device Lot Number: 74B1702177
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/06/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/19/2018
• Initial Date FDA Received: 03/28/2018
• Supplement Dates Manufacturer Received: 04/16/2018
• Supplement Dates FDA Received: 05/01/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/15/2017
• 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