MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON NEBULIZER,LARGE VOLUME,VAR CONCENTRATIO

Catalog Number 1770

Device Problem Failure to Deliver (2338)

Patient Problem Respiratory Distress (2045)

Event Date 10/05/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Additional information has been requested regarding the patient condition.A visual, dimensional, and functional inspection of the device involved in the complaint could not be conducted since neither the product nor a picture of the alleged defect was not provided.The device history record (dhr) of batch number (b)(4) has been reviewed and no issues or discrepancies were found which could potentially relate to this complaint.No non conformance reports were originated for the lot in question that can be associated to the complaint reported.Dhr shows that the product was assembled and inspected according to our specifications.A corrective action cannot be applied since in order to perform a proper investigation it is necessary to evaluate the sample involved in the incident, to identify the alleged defect reported and to investigate its root cause.Customer complaint cannot be confirmed based only on the information provided.The root cause is unknown at this time.If the device sample, or updated patient condition information, becomes available this report will be updated accordingly.

Event Description

Customer alleges that the device used for humidification stopped working, and caused patients secretion to dry and caused a mucus plug.It is reported that the alleged event caused a "medical 25" which is a life threatening respiratory compromise.At this time, it is reported that there was no death.

Manufacturer Narrative

(b)(4).Additional information was received indicating that the user facility has reported that the device sample was misplaced and will not be available for investigation.

Event Description

Customer alleges that the device used for humidification stopped working, and caused patients secretion to dry and caused a mucus plug.It is reported that the alleged event caused a "medical 25" which is a life threatening respiratory compromise.At this time, it is reported that there was no death.

• Brand Name: HUDSON NEBULIZER,LARGE VOLUME,VAR CONCENTRATIO
• Type of Device: NEBULIZER
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC
• Manufacturer (Section G): TELEFLEX MEDICAL; parque industrial finsa; nuevo laredo 88275 ; MX 88275
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9194334854
• MDR Report Key: 6095848
• MDR Text Key: 59767662
• Report Number: 3004365956-2016-00424
• Device Sequence Number: 1
• Product Code: CAF
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/02/2016

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: 1770
• Device Lot Number: 74D1601682
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/02/2016
• Initial Date FDA Received: 11/11/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/16/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/13/2016
• 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
• Treatment: ARTIFICIAL AIRWAY
• Patient Outcome(s): Other