MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON AQUAPAK 340 SW,340 ML W/040 ADAPTOR,JAP; HUMIDIFIER NEBULIZER KIT

Catalog Number 003-40J

Device Problem Leak/Splash (1354)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/07/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that "water leaked from the connecting part of the humidifier adaptor and the bottle before use on a patient.Therefore, a new unit was opened instead".No patient involvement reported.

Event Description

It was reported that "water leaked from the connecting part of the humidifier adaptor and the bottle before use on a patient.Therefore, a new unit was opened instead".No patient involvement reported.

Manufacturer Narrative

(b)(4).One 340 ml water reservoir 003-40j lot 21b004 was received for evaluation.The bottle was used with the adaptor port punctured and the trigger removed.The bottle was completely dried.Visual inspection shows no defects or leaks of the bottle.The bottle was filled with water.The adaptor body was removed from the bottle for visual inspection and then re-attached.The adaptor body made a stable connection to the bottle.The adaptor snap cap made a stable connection to the flowmeter.The water bottle/adaptor assembly was applied to the flowmeter.The flowmeter was set to 1 liter per minute and bubbles were observed in the bottle.The connection was stable.No leaks appeared coming from the adaptor or bottle when flowmeter was at 1 liter per minute.No leaks appeared coming from the adaptor or bottle when flow was increased to 8 liters per minute.A device history record review was performed and no relevant findings were identified.The complaint could not be confirmed.No issues were found with the returned sample.

• Brand Name: HUDSON AQUAPAK 340 SW,340 ML W/040 ADAPTOR,JAP
• Type of Device: 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: 12554114
• MDR Text Key: 274010699
• Report Number: 1417411-2021-00019
• Device Sequence Number: 1
• Product Code: OGG
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: 003-40J
• Device Lot Number: 21B004
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/29/2021
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/08/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/05/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1