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

Catalog Number 003-40J

Device Problem Hole In Material (1293)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/16/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A visual, dimensional, and functional inspection of the device involved in the complaint could not be conducted since the device was not returned at the time of this report.Device history record review shows no issues that may have contributed to any quality issues reported.All process parameters were within specification , and all in-process qa inspections were acceptable.As there is no device sample to do a complete investigation at this time, the customer complaint cannot be confirmed.Teleflex will continue to monitor customer complaints related to "pinhole on top of bottle" on water bottle products.If the device becomes available at a later date this report will be updated accordingly.

Event Description

Customer complaint alleges that the aquapak user found a "pinhole on the top of the bottle".The alleged defect was detected during use.There was no harm or injury reported to the patient.Patient's condition was reported as "fine".

Manufacturer Narrative

(b)(4).A 340 ml water bottle with an 040 humidifier adaptor was received for evaluation.Visual inspection of the water bottle confirms a pin hole on the top of the water bottle.Pinhole in the water bottle was identified but is not related to manufacturing.Review of defect sample with production did not confirm issue occurred during the manufacturing process.Per production supervisor, if this occurred during manufacturing, the bottle would show other areas of deformation.No additional issues were identified with the bottle.Issue must have occurred during shipping and or handling.The complaint was confirmed; however, a conclusion code could not be found.

Event Description

Customer complaint alleges that the aquapak user found a "pinhole on the top of the bottle".The alleged defect was detected during use.There was no harm or injury reported to the patient.Patient's condition was reported as "fine".

• Brand Name: HUDSON AQUAPAK 340 SW,340 ML W/040 ADAPTOR,JAP
• 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: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9194334854
• MDR Report Key: 6354334
• MDR Text Key: 68221757
• Report Number: 1417411-2017-00010
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/16/2017

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
• Device Operator: No Information
• Device Expiration Date: 06/30/2020
• Device Catalogue Number: 003-40J
• Device Lot Number: 351167
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/29/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/16/2017
• Initial Date FDA Received: 02/23/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/05/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/20/2016
• 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