MAUDE Adverse Event Report: HUDSON 22MM HTD NIV CIRC KIT W/FILTER; HUMIDIFIER NEBULIZER KIT

Model Number	IPN913839
Medical Device Problem Codes	Fracture (1260); Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/05/2021
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 "when they use the circuits with this lot number, the vent throws an alarm until the circuit is changed to one not from this lot number.Pt care is not affected except by the alarm noise.No clinical deterioration".Patient condition reported as "fine".
Additional Manufacturer Narrative
(b)(4).The customer returned one niv circuit part number 870-98kitf (22mm heated niv circ kit w/filter) for analysis.While performing the visual inspection test on the received sample a crack was found on the connector.Leak testing was performed and the sample failed due to the cracked connector.No other issues were found.The complaint was confirmed; however, a root cause for the issue could not be identified.Corrected data: section f.10.- medical device problem code corrected to 1260 section h.6.- medical device problem code corrected to 1260.
Event or Problem Description
It was reported "when they use the circuits with this lot number, the vent throws an alarm until the circuit is changed to one not from this lot number.Pt care is not affected except by the alarm noise.No clinical deterioration".Patient condition reported as "fine".

• Brand Name: HUDSON 22MM HTD NIV CIRC KIT W/FILTER
• Common Device Name: HUMIDIFIER NEBULIZER KIT
• MDR Report Key: 12256670
• Report Number: 3004365956-2021-00255
• Device Sequence Number: 14702999
• Product Code: OGG
• UDI-Device Identifier: 14026704660473
• UDI-Public: 14026704660473
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• 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): 07/07/2021

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: 05/07/2025
• Device Model Number: IPN913839
• Device Catalogue Number: 870-98KITF
• Device Lot Number: 74F2000191
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/15/2021
• Initial Date Received by Manufacturer: 07/07/2021
• Supplement Date Received by Manufacturer: 08/31/2021
• Initial Report FDA Received Date: 07/30/2021
• Supplement Report FDA Received Date: 09/01/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/01/2020
• 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: VENTILATOR; VENTILATOR