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

Catalog Number 1882

Device Problem Device Rinsing Issue (2309)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/15/2017

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 was not returned to the manufacturer at the time of this report.A picture of the alleged defect was not provided.A device history record review shows that the product was assembled and inspected according to our specifications.Customer complaint cannot be confirmed based only on the information provided.In order to perform a proper investigation, and determine the source of the alleged defect reported, it is necessary to evaluate the sample involved in this complaint.If the sample becomes available at a later date, this investigation will be updated with the evaluation results.

Event Description

Customer complaint alleges that "it was found that the mouthpiece and tee were missing from the package." it was reported that the alleged defect was detected during use.It was reported there was a delay in treatment but no harm to the patient.Patient condition reported as "fine.".

Manufacturer Narrative

(b)(4).The sample was returned for evaluation.During the visual inspection, it was revealed that the t-connector and mouthpiece were not returned.The reported complaint of a missing mouthpiece and t-connector was confirmed through visual inspection of the returned sample.The returned components were not received in their original packaging.A review of the device history records (dhr) for the lot number reported did not reveal any manufacturing related issues.Therefore, the root cause of this investigation could not be determined.

Event Description

Customer complaint alleges that " it was found that the mouthpiece and tee were missing from the package".It was reported that the alleged defect was detected during use.It was reported there was a delay in treatment but no harm to the patient.Patient condition reported as "fine".

• Brand Name: HUDSON MICRO MIST NEBULIZER W/TEE,TBG & MTHPC
• 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: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9194334854
• MDR Report Key: 6365988
• MDR Text Key: 68596480
• Report Number: 3004365956-2017-00078
• Device Sequence Number: 1
• Product Code: CAF
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 1882
• Device Lot Number: 74B1501068
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/29/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/18/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/04/2015
• 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