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

Model Number	IPN040620
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/23/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn#: (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.
Event or Problem Description
It was reported that "the user found the oxygen did not seem to flow during use as he/she saw the ball of a floating type flowmeter did not float.Therefore, he/she replaced the nebulizer adaptor with another one, then the oxygen flowed without problem".No patient injury or consequence reported.Patient condition reported as "fine".
Additional Manufacturer Narrative
(b)(4).The sample was returned for evaluation.Signs of use were observed since the sample was not received in its original package.No other issues were found.Functional testing was performed and no issues were encountered.Based on the investigation performed, the reported complaint could not be confirmed.There were no issues found with the returned device.The unit functioned as intended.
Event or Problem Description
It was reported that "the user found the oxygen did not seem to flow during use as he/she saw the ball of a floating type flowmeter did not float.Therefore, he/she replaced the nebulizer adaptor with another one, then the oxygen flowed without problem".No patient injury or consequence reported.Patient condition reported as "fine".

• Brand Name: HUDSON NEBULIZER ADAPTOR 033,STERILE,JAPANESE
• Common Device Name: NEBULIZER (DIRECT PATIENT INTE
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• MDR Report Key: 12169586
• Report Number: 3004365956-2021-00208
• Device Sequence Number: 3820816
• Product Code: CAF
• UDI-Device Identifier: 04026704581290
• UDI-Public: 04026704581290
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K153010
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/23/2021

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
• Operator of Device: No Information
• Device Model Number: IPN040620
• Device Catalogue Number: 031-33J
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/13/2021
• Initial Date Received by Manufacturer: 06/23/2021
• Supplement Date Received by Manufacturer: 08/05/2021
• Initial Report FDA Received Date: 07/14/2021
• Supplement Report FDA Received Date: 08/06/2021
• 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: FLOWMETER; FLOWMETER