MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON NEBULIZER ADAPTOR 033,STERILE,JAPANESE; HUMIDIFIER NEBULIZER KIT

Model Number	IPN040620
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/04/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that "the user found it difficult to connect the adaptor to the flowmeter as the connecting part was so unstable.Therefore, a new unit was used instead".No patient involvement reported.
Event or Problem Description
It was reported that "the user found it difficult to connect the adaptor to the flowmeter as the connecting part was so unstable.Therefore, a new unit was used instead".No patient involvement reported.
Additional Manufacturer Narrative
Qn#: (b)(4).The sample was returned for evaluation.A visual exam was performed and it was observed that the nut adaptor did not spin freely.No other issues were observed.Oxygen entrainment testing was performed and it was noticed during setup that the assembly of the nut adaptor and the upper body was unstable.Even with that condition, the sample was able to be tested on oxygen entrainment testing, but the sample failed the test.A visual inspection was performed and wear was found on the internal tabs of the adaptor.Based on the investigation performed, the complaint is confirmed.Although the complaint is confirmed, there is not sufficient evidence to assure that this issue was originated during the manufacturing assembly or molding process.The wear on the internal tabs of the adaptor was most likely caused by the end user during the connection of the adaptor into the flowmeter that causes an unstable connection issue.

• Brand Name: HUDSON NEBULIZER ADAPTOR 033,STERILE,JAPANESE
• Common Device Name: HUMIDIFIER NEBULIZER KIT
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• Manufacturer (Section G): TELEFLEX MEDICAL; 900 west university dr.; arlington heights IL 60004
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 12712389
• Report Number: 1417411-2021-00020
• Device Sequence Number: 11955607
• Product Code: OGG
• UDI-Device Identifier: 04026704581290
• UDI-Public: 04026704581290
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/04/2021

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 Expiration Date: 03/04/2025
• Device Model Number: IPN040620
• Device Catalogue Number: 031-33J
• Device Lot Number: 74C2000184
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/04/2021
• Supplement Date Received by Manufacturer: 03/11/2022
• Initial Report FDA Received Date: 10/28/2021
• Supplement Report FDA Received Date: 03/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/02/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: N/A.; N/A.
• Patient Sex: Unknown