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

Model Number	IPN040620
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/26/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed and no relevant findings were identified.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 or Problem Description
It was reported "the connecting part of the adaptor to the flowmeter was unstable and the adaptor got detached during use.The adaptor was replaced with a new unit, but the same issue occurred.The third unit was connected properly".No patient harm or injury reported.Patient condition reported as "fine".
Event or Problem Description
It was reported "the connecting part of the adaptor to the flowmeter was unstable and the adaptor got detached during use.The adaptor was replaced with a new unit, but the same issue occurred.The third unit was connected properly".No patient harm or injury reported.Patient condition reported as "fine".
Additional Manufacturer Narrative
(b)(4).The sample was returned for evaluation.A visual exam was performed and no issues were observed.Oxygen entrainment testing was performed and during the setup it was observed 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; however the sample failed the testing.After the testing was finished, the adaptor was carefully disassembled from the upper body and it was visually inspected.During the visual inspection wear was found on the internal tabs.A device history record review was performed and no relevant findings were identified.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: NEBULIZER (DIRECT PATIENT INTE
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• MDR Report Key: 11527979
• Report Number: 3004365956-2021-00079
• Device Sequence Number: 12054479
• 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): 02/26/2021

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 Expiration Date: 09/23/2024
• Device Model Number: IPN040620
• Device Catalogue Number: 031-33J
• Device Lot Number: 74J1902719
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/17/2021
• Initial Date Received by Manufacturer: 02/26/2021
• Supplement Date Received by Manufacturer: 04/06/2021
• Initial Report FDA Received Date: 03/19/2021
• Supplement Report FDA Received Date: 04/08/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1