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

Catalog Number 031-28

Device Problem Fluid/Blood Leak (1250)

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

Event Date 05/07/2018

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.The device history record (dhr) has been reviewed and no issues or discrepancies were found which could potentially relate to this c omplaint.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 to confirm the alleged defect, and determine the root cause.Root cause is unknown.If the sample becomes available this report will be updated with the evaluation results.Teleflex will continue to monitor and trend for complaints of this nature.

Event Description

Customer complaint alleges the " nebulizer adapter which was attached to 040-00.The complaint was that water was spraying out the adapter and puddling on the floor." alleged issue reported as occurred during use.No patient injury or consequence reported.

• Brand Name: HUDSON NEBULIZER ADAPTOR 028,STERILE,SHELFPAK
• Type of Device: NEBULIZER (DIRECT PATIENT INTERFACE)
• 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: 7541811
• MDR Text Key: 109231131
• Report Number: 3004365956-2018-00164
• Device Sequence Number: 1
• Product Code: CAF
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/10/2018

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: 031-28
• Device Lot Number: 74D1601199
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/10/2018
• Initial Date FDA Received: 05/24/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/07/2016
• 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