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

Catalog Number 400301

Device Problem Failure to Deliver (2338)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/08/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device involved in this complaint has not been received by the manufacturer for evaluation at the time of this report.Review of manufacturing event log shows no issues that may have contributed to any quality issues reported.All process parameters were within specification.The sample is needed for a proper and thorough investigation.Complaint cannot be confirmed.Root cause cannot be determined.If the sample becomes available, this report will be updated with the evaluation results.

Event Description

Customer complaint alleges "when using the aquapak, there were no bubbles when the oxygen passes." there was no report of patient impact or consequence.

Event Description

Customer compalint alleges "when using the aquapak, there were no bubbles when the oxygen passes." there was no report of patient impact or consequence.

Manufacturer Narrative

Qn#(b)(4).A used 340 ml water bottle was received for evaluation.The top port was punctured and the trigger was removed.Visual inspection shows an slight deformity in the plastic near the adaptor port and top of the water bottle.No other visual defects were observed.A functional inspection could not be performed since the humidifier adaptor was not received along with the complaint sample.Although this visual deformity is not an entirely open channel and should most likely not cause any issues, there have been a number of confirmed complaints related to an open channel causing no bubbles at low flow.This visual defect is related to that issue and is an identified manufacturing error.Because of this, the complaint is confirmed.A non-conformance was opened, and this issue has been resolved.

• Brand Name: HUDSON AQUAPAK 301 SW,340 ML,INTL
• Type of Device: RESPIRATORY GAS HUMIDIFIER
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC
• MDR Report Key: 8264762
• MDR Text Key: 133935750
• Report Number: 1417411-2019-00008
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 01/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/21/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 09/14/2021
• Device Catalogue Number: 400301
• Device Lot Number: 474177
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/31/2019
• Date Manufacturer Received: 02/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NONE REPORTED.; NONE REPORTED.