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

Model Number IPN049284

Device Problem Failure to Deliver (2338)

Patient Problem Airway Obstruction (1699)

Event Date 01/28/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review could not be conducted since the lot number of the device was not provided.Without the device to evaluate, the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.If the sample becomes available at a later date a follow up report will be submitted with investigation results.

Event Description

It was reported "the product was in place 3 days when the rt was called to the bedside of a trach patient who was coughing and struggling to expectorate.On arrival, the rt noted very dry secretions which were unable to be suctioned easily without instilling saline to loosen them.At one point the patient coughed so forcefully that the trach sutures popped out.On inspection of the aerosol humidity, the nebulizer was noted as malfunctioning, i.E.No aerosolization occurring despite correct setup of the equipment and a full water bottle.He took the nebulizer off the bottle, didn't note any obvious issues with it, rethreaded it on a new bottle and spiked it but it was still not producing aerosol humidity".It was reported no resuscitation efforts were required.Patient condition reported to be "fine".

Manufacturer Narrative

(b)(4), the sample was returned for evaluation.A visual exam was performed and no defects were observed.Functional testing was also performed and no issues were encountered.The complaint could not be confirmed.No issues were found with the returned sample.The device functioned as intended.

Event Description

It was reported "the product was in place 3 days when the rt was called to the bedside of a trach patient who was coughing and struggling to expectorate.On arrival, the rt noted very dry secretions which were unable to be suctioned easily without instilling saline to loosen them.At one point the patient coughed so forcefully that the trach sutures popped out.On inspection of the aerosol humidity, the nebulizer was noted as malfunctioning, i.E.No aerosolization occurring despite correct setup of the equipment and a full water bottle.He took the nebulizer off the bottle, didn't note any obvious issues with it, rethreaded it on a new bottle and spiked it but it was still not producing aerosol humidity".It was reported no resuscitation efforts were required.Patient condition reported to be "fine".

• Brand Name: HUDSON NEBULIZER ADAPTOR 028, SHELFPAK
• Type of Device: NEBULIZER (DIRECT PATIENT INTE
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• MDR Report Key: 11558040
• MDR Text Key: 241930982
• Report Number: 3004365956-2021-00104
• Device Sequence Number: 1
• Product Code: CAF
• UDI-Device Identifier: 14026704627735
• UDI-Public: 14026704627735
• Combination Product (y/n): N
• PMA/PMN Number: K141214
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 03/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: IPN049284
• Device Catalogue Number: 031-28
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/05/2021
• Date Manufacturer Received: 04/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NONE REPORTED; NONE REPORTED
• Patient Outcome(s): Life Threatening; Required Intervention