MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON AQUAPAK 700 SW,760 ML,JAPAN; HUMIDIFIER

Catalog Number 037-00J

Device Problems Device Damaged Prior to Use (2284); Defective Component (2292)

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

Event Date 05/25/2015

Event Type  malfunction  

Event Description

The customer alleges that the connector of the bottle was damaged.No patient injury reported.

Event Description

The customer alleges that the connector of the bottle was damaged.No patient injury reported.

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.A device history record reviewed was conducted and showed no issues that may have contributed to any quality issues reported.All process parameters were within specification.All in-process qa inspections shows one non-conformance that has no impact on the quality issue reported.Non-conforming material was sorted for a defect, re-inspected, and found to be acceptable per internal specification.No sample available from the customer to investigate.Teleflex will continue to monitor feedback from the customers on issues related to a damaged bottle connector found at inspection or prior to use.Root cause is unknown.

Manufacturer Narrative

Qn#(b)(4).The sample was returned for evaluation.A visual exam was performed and it was found that the bottle was empty due to a drain hole being created by the customer.It was also noticed that the top of the port was slightly bent.No other issues were found.Based on the investigation performed, the reported complaint was confirmed.It was determined that the water bottle was incorrectly packaged when the plastic was still too warm, which resulted in a deformed bottle due to a pressure point during packaging, loading, handling or shipping.Manufacturer will continue to monitor feedback from customers on issues related to a damaged bottle connector found at inspection on water bottle products.

• Brand Name: HUDSON AQUAPAK 700 SW,760 ML,JAPAN
• Type of Device: 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: 4844638
• MDR Text Key: 5934227
• Report Number: 1417411-2015-00104
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/02/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 02/28/2019
• Device Catalogue Number: 037-00J
• Device Lot Number: 021150
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/15/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/21/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/23/2015
• 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