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

Catalog Number 1883

Device Problem Obstruction of Flow (2423)

Patient Problem No Patient Involvement (2645)

Event Date 08/20/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device has not been received by the manufacturer for evaluation at the time of this initial report.The device history record (dhr) has been reviewed and no issues or discrepancies were found which could potentially be related to this complaint.The dhr shows that the product was assembled and inspected according to our specifications.Customer complaint cannot be confirmed based on the information provided.To perform a proper investigation and determine the source of defect reported it is necessary to evaluate the sample involved in this complaint.If the sample becomes available this report will be updated with the evaluation results.

Event Description

Customer complaint alleges " during pretest, the gas did not go through the supply tubing, which caused its coming off from nebulizer".It was reported there was no patient involvement.

Manufacturer Narrative

(b)(4).The sample was returned for evaluation.A visual exam was performed and no defects were observed.Functional testing was also performed and no issues were encountered.The sample was within specification.Based on the investigation performed, the complaint could not be confirmed.There were no issues found with the returned sample.The device functioned as intended.

Event Description

Customer complaint alleges " during pretest, the gas did not go through the supply tubing, which caused its coming off from nebulizer".It was reported there was no patient involvement.

• Brand Name: HUDSON MICRO MIST NEBULIZER W/TEE,TBG & MTHPC
• Type of Device: NEBULIZER (DIRECT PATIENT INTE
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC
• MDR Report Key: 7842883
• MDR Text Key: 119085374
• Report Number: 3004365956-2018-00256
• Device Sequence Number: 1
• Product Code: CAF
• Combination Product (y/n): N
• PMA/PMN Number: K930525
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 08/20/2018

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: 1883
• Device Lot Number: 74J1702434
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/07/2018
• Initial Date Manufacturer Received: 08/20/2018
• Initial Date FDA Received: 09/04/2018
• Supplement Dates Manufacturer Received: 10/12/2018
• Supplement Dates FDA Received: 10/15/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NONE REPORTED.; NONE REPORTED.