MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON AQUAPAK 301 SW,340 ML,INTL; RESPIRATORY GAS HUMIDIFIER

Catalog Number 400301

Device Problem Cut In Material (2454)

Patient Problems Low Oxygen Saturation (2477); No Known Impact Or Consequence To Patient (2692)

Event Date 06/24/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A visual, functional, and dimensional inspection of the product involved in the complaint could not be conducted since the product was not returned.The device history record review was conducted and review of manufacturing event log showed no issues that may have contributed to a ny quality issues reported.All process parameters were within specification.All in-process qa inspections were acceptable.No sample available from the customer to investigate.Complaint not confirmed.Root cause unknown.Teleflex will continue to monitor feedback from the customers on issues related to leaking bottle found at inspection on water bottle products.

Event Description

The customer alleges that the patient used the device for approximately 6 days and significantly de-saturated.The patient was hospitalized.The device was found to have a cut.The patient is reported as better/fine.

• Brand Name: HUDSON AQUAPAK 301 SW,340 ML,INTL
• Type of Device: RESPIRATORY GAS HUMIDIFIER
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC
• Manufacturer (Section G): TELEFLEX MEDICAL; 900 west university dr.; arlington heights IL 60004
• Manufacturer Contact: margie burton, rn ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9194334965
• MDR Report Key: 6030031
• MDR Text Key: 57464547
• Report Number: 1417411-2016-00127
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 10/04/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 400301
• Device Lot Number: 280167
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/04/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Hospitalization