MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON NEBULIZER ADAPTOR 033,STERILE,SHELFPAK; NEBULIZER (DIRECT PATIENT INTE

Catalog Number 031-33

Device Problem Gas/Air Leak (2946)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/22/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.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

Customer reported the nebulizers are not working.It was reported "they leak when attached to the wall.We called in engineering and the problem followed the nebs.We then called up an outside vendor and we attached the nebs to tanks and the problem still followed the nebs".It was reported the issue was detected during use on a patient and affected oxygen flow to the patient.No patient harm was reported.The patient's condition is reported as "stable".

Manufacturer Narrative

(b)(4).The actual sample was not returned; however, the customer sent back four (4) representative samples of product code 031-33 "nebulizer adaptor 033 , sterile, shelfpack" for investigation.A visual exam was performed and no defects were observed.The representative samples were then functionally tested on the oxygen entrainment test and no issues were encountered.A device history record review was performed on the lot number of the returned samples (74l1900777).There were no issues or discrepancies 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.The dhr shows that the product was assembled and inspected according to specifications.The complaint could not be confirmed as the actual sample is needed to perform a proper investigation and to establish a root cause.

Event Description

Customer reported the nebulizers are not working.It was reported "they leak when attached to the wall.We called in engineering and the problem followed the nebs.We then called up an outside vendor and we attached the nebs to tanks and the problem still followed the nebs".It was reported the issue was detected during use on a patient and affected oxygen flow to the patient.No patient harm was reported.The patient's condition is reported as "stable.".

• Brand Name: HUDSON NEBULIZER ADAPTOR 033,STERILE,SHELFPAK
• Type of Device: NEBULIZER (DIRECT PATIENT INTE
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• MDR Report Key: 10687798
• MDR Text Key: 211673357
• Report Number: 3004365956-2020-00201
• Device Sequence Number: 1
• Product Code: CAF
• Combination Product (y/n): N
• PMA/PMN Number: K141214
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,user facility
• Type of Report: Initial,Followup
• Report Date: 09/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/15/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 031-33
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/09/2020
• Date Manufacturer Received: 11/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NONE REPORTED.; NONE REPORTED.; NONE REPORTED.