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

Model Number	IPN049284
Medical Device Problem Code	Failure to Deliver (2338)
Health Effect - Clinical Code	Respiratory Arrest (4461)
Date of Event	01/07/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Qn# (b)(4).
Event or Problem Description
Complaint was reported "patient has a trach with high humidity trach mask.Patient had a respiratory arrest secondary to mucus plug.This high humidity set-up does not provide the same amount of humidity as the previous set up.Cannot determine that the product caused the mucus plug and respiratory arrest, however, more humidification would have reduced the risk of developing a mucus plug".Patient had a respiratory arrest secondary to mucus plug.The teleflex humidity set-up was changed to the thera-mist lvn-high flow (smiths medical)set-up.Additional information was requested but not received at the time of this report.Patient condition unknown.
Event or Problem Description
Complaint was reported "patient has a trach with high humidity trach mask.Patient had a respiratory arrest secondary to mucus plug.This high humidity set-up does not provide the same amount of humidity as the previous set up.Cannot determine that the product caused the mucus plug and respiratory arrest, however, more humidification would have reduced the risk of developing a mucus plug".Patient had a respiratory arrest secondary to mucus plug.The teleflex humidity set-up was changed to the thera-mist lvn-high flow (smiths medical)set-up.Additional information was requested but not received at the time of this report.Patient condition unknown.
Additional Manufacturer Narrative
(b)(4).Complaint verification testing could not be performed as it was reported that the sample is not available for return.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.

• Brand Name: HUDSON NEBULIZER ADAPTOR 028, SHELFPAK
• Common Device Name: NEBULIZER (DIRECT PATIENT INTE
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• MDR Report Key: 11323753
• Report Number: 3004365956-2021-00039
• Device Sequence Number: 3283330
• Product Code: CAF
• UDI-Device Identifier: 14026704627735
• UDI-Public: 14026704627735
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K141214
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Model Number: IPN049284
• Device Catalogue Number: 031-28
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/22/2021
• Supplement Date Received by Manufacturer: 02/18/2021
• Initial Report FDA Received Date: 02/12/2021
• Supplement Report FDA Received Date: 02/22/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NONE REPORTED; NONE REPORTED; NONE REPORTED
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention