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

Catalog Number 1884

Device Problem Failure to Deliver (2338)

Patient Problem No Patient Involvement (2645)

Event Date 05/13/2019

Event Type  malfunction  

Manufacturer Narrative

Qn# (b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.The customer did provide a photo and from review of the photo it was observed there was an occlusion on the nebulizer assembly.A device history record review was performed and no relevant findings were identified.The reported complaint was confirmed through visual inspection of the received picture as it was observed that the nebulizer assembly is occluded.Although the complaint is confirmed, there is not sufficient evidence to assure this issue originated during the manufacturing process.The root cause for the condition reported could not be identified without the actual sample.If the sample becomes available at a later date a follow up report will be submitted with investigation results.

Event Description

The complaint is reported as: "(b)(6) 2019, in (b)(6) hospital in (b)(6), no mist came from the tube during function test, changing one and it worked well.Then check the tube with issue and found it was blocked and a mosquito was in it".

Manufacturer Narrative

(b)(4).A visual inspection of the product involved in the complaint was performed on a sample provided by the customer of product code 1884 micro mist nebulizer w/tee, which consisted of a jet and jar.A foreign particle that looks like an insect can be observed inside the packaging bag.No other issues were found.Customer complaint is confirmed based on the visual inspection performed on the sample provided by the customer, however it is not possible to determine where on the distribution chain of the product it got contaminated.Although the insect was inside the product package, the size of the insect allowed it to go inside by the vent holes located on the packaging bag.At the manufacturing facility proper pest controls are in place to avoid insect contamination; pallets used to load the products are pest treated; therefore, it is not possible that the contamination occurred during the manufacturing process of the product.

Event Description

The complaint is reported as: "(b)(6) 2019,in haojiang people's hospital in shantou city, no mist came from the tube during function test, changing one and it worked well.Then check the tube with issue and found it was blocked and a mosquito was in it.".

• Brand Name: HUDSON MICRO MIST NEBULIZER W/TEE
• Type of Device: NEBULIZER (DIRECT PATIENT INTE
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC
• MDR Report Key: 8696659
• MDR Text Key: 148161669
• Report Number: 3004365956-2019-00153
• 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,distri
• Type of Report: Initial,Followup
• Report Date: 05/22/2019

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: 1884
• Device Lot Number: 74A1702524
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/10/2019
• Initial Date Manufacturer Received: 05/22/2019
• Initial Date FDA Received: 06/13/2019
• Supplement Dates Manufacturer Received: 07/04/2019
• Supplement Dates FDA Received: 07/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1