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

Catalog Number 031-28

Device Problem Inaccurate Delivery (2339)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/19/2018

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical product: (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) of batch number 74g1801922 has been reviewed and no issues or discrepancies were found which could potentially relate to this complaint.Dhr shows that the product was assembled and inspected according to our specifications.The device sample is needed for a proper and thorough investigation.Customer complaint cannot be confirmed based only on the information provided.Root cause cannot be determined.No corrective actions can be established.If the device becomes available this report will be updated.Teleflex will continue to monitor customer feedback for complaints of this nature.

Event Description

Customer complaint alleges the device "is not adequately humidifying trach patients", causing a build up of dried secretions in the tracheostomy tube.No patient injury or complication was reported.Patient condition reported as fine.

• Brand Name: HUDSON NEB ADAPTOR 028, NON-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: 8264816
• MDR Text Key: 134897175
• Report Number: 3004365956-2019-00012
• 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: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/21/2019
• 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: 74G1801922
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/08/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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