MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON AQUAPAK 301 SW,340 ML,JAPAN; BUBBLE HUMIDIFIER

Catalog Number 003-01J

Device Problem Partial Blockage (1065)

Patient Problems No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)

Event Date 06/15/2015

Event Type  malfunction  

Event Description

The md insisted that some of the holes on the bottom of the device were blocked.A new product was used without incident.

Manufacturer Narrative

(b)(4).The device sample was not returned for evaluation at the time of this report.

Manufacturer Narrative

(b)(4).The sample was returned for evaluation.A visual exam was performed and there was no visible sign of any damage to the water bottle except there was a 10cm bubble inside.This bubble formed during the bottle blowing process and it was from the same material as the water bottle itself.Although approx.1/4 of the holes were occluded on the diffuser, the water bottle sample passed back pressure test.Functional testing was performed and it was found that 1/4 of the holes were occluded and 3/4 were free of occlusion.A review of the manufacturing event log shows that 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.Based on the investigation performed, the reported complaint could not be confirmed.There were no functional issues found with the returned device.

Event Description

The md insisted that some of the holes on the bottom of the device were blocked.A new product was used without incident.

• Brand Name: HUDSON AQUAPAK 301 SW,340 ML,JAPAN
• Type of Device: BUBBLE 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: 4871403
• MDR Text Key: 5861249
• Report Number: 1417411-2015-00113
• 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: Foreign,Health Professional,User Facility,Company Representative,company represent
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/16/2015

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: Health Professional
• Device Expiration Date: 12/31/2018
• Device Catalogue Number: 003-01J
• Device Lot Number: 694147
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/29/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/16/2015
• Initial Date FDA Received: 06/26/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/18/2014
• 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