MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON MICRO MIST NEBULIZER W/TEE,TBG & MTHPC; NEBULIZER, DIRECT PATIENT

Catalog Number 1883

Device Problem Failure to Deliver (2338)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/08/2019

Event Type  malfunction  

Manufacturer Narrative

Qn#(b)(4).Under mdr# 3004365956-2019-00068.The initial report was accepted via the emdr system.An attempt was made to submit a follow-up report on 04/11/2019; however, that report failed with the error message: "this group of submissions could not be processed because at least 1 submission failed hl7 validation.Report numbers that could be extracted are displayed above.The following message is the first error that was encountered: the xml data is invalid.Further elements required under element." several additional attempts were made to submit the follow-up report; however, they were all unsuccessful.The cdrh emdr office was contacted and (b)(6) was helping to resolve the issue.The problem could not be identified as to why the report would not be accepted.It was decided that a new complaint would be created in our sap system and an initial/final report will be submitted.The new mdr for this report is 3004365956-2019-00172.Investigation results: the sample was returned for evaluation.A visual exam was performed and no defects were observed.A functional inspection was performed to determine if the nebulizer would mist.The returned tubing was used to connect the nebulizer unit to the air flowmeter.5cc of water was added to the returned nebulizer unit and tubing was connected to an air flowmeter and the pressure was increased to 8 lpm.Mist was produced from the chamber of the nebulizer.Based on the investigation performed, the reported complaint could not be confirmed.There were no issues found with the returned sample.The unit functioned as intended.Other remarks: n/a.

Event Description

The customer complaint alleges that the device did not "spray" nebulization of the medication during use on a patient.There was no report of patient injury.Patient condition reported as fine.

• Brand Name: HUDSON MICRO MIST NEBULIZER W/TEE,TBG & MTHPC
• Type of Device: NEBULIZER, DIRECT PATIENT
• 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: 8691212
• MDR Text Key: 147872763
• Report Number: 3004365956-2019-00172
• Device Sequence Number: 1
• Product Code: CAF
• Combination Product (y/n): N
• Reporter Country Code: KS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/05/2019

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: 1883
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2019
• Initial Date Manufacturer Received: 03/05/2019
• Initial Date FDA Received: 06/12/2019
• Was Device Evaluated by Manufacturer?: Yes
• 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