MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON NEBULIZER ADAPTOR 028,STERILE,SHELFPAK; NEBULIZER (DIRECT PATIENT INTE

Catalog Number 031-28

Device Problem No Flow (2991)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/22/2018

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 relate to this c omplaint.All materials used during the assembly met current specifications.Dhr shows that the product was assembled and inspected according to our specifications.Customer complaint cannot be confirmed due the lack of product sample to perform a proper investigation and determine the root cause.No corrective actions can be assigned at this time.If the sample becomes available this report will be updated with the evaluation results.

Event Description

Customer complaint alleges while trying to put a patient on heated aerosol (large volume nebulizer),the device failed to perform up to 10l/min of flow.Alleged issue reported during patient use.There was no patient harm reported.

• Brand Name: HUDSON NEBULIZER ADAPTOR 028,STERILE,SHELFPAK
• 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: linda woodall ; 3015 carrington mill blvd; morrisville 27560 ; 9196942566
• MDR Report Key: 7593547
• MDR Text Key: 110852306
• Report Number: 3004365956-2018-00174
• Device Sequence Number: 1
• Product Code: CAF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K141214
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 031-28
• Device Lot Number: 74M1700746
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 05/22/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/04/2017
• 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