MAUDE Adverse Event Report: TELEFELX MEDICAL HUDSON AQUAPAK 340 SW, 340 ML W/040 ADAPTOR, FRE; BUBBLE HUMIDIFIER

Catalog Number 003-40F

Device Problems Burst Container or Vessel (1074); Improper or Incorrect Procedure or Method (2017)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/08/2013

Event Type  malfunction  

Event Description

The event is reported as: the customer alleges that as soon as the nurse used the aquapak, oxygen was not correctly administered to the patient.The nurse additionally screwed the bottle and the bottle burst.The nurse obtained another device and no issues were apparent.There was no injury to the patient.The patient condition is reported as fine.

Manufacturer Narrative

A visual, dimensional and functional inspection could not be conducted since the product was not returned for evaluation.A review of the dhr (device history record) concluded: review of manufacturing event log: shows 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 returned from the customer to investigate.Complaint not confirmed.Root cause - unknown.Teleflex will continue to monitor feedback from the customers on issues related to torn package found at inspection on adaptor products.

• Brand Name: HUDSON AQUAPAK 340 SW, 340 ML W/040 ADAPTOR, FRE
• Type of Device: BUBBLE HUMIDIFIER
• Manufacturer (Section D): TELEFELX MEDICAL; arlington heights IL
• Manufacturer (Section G): TELEFELX; 900 west university dr.; arlington heights IL 60004
• Manufacturer Contact: margie burton, rn ; po box 12600; durham, NC 27709 ; 9194334965
• MDR Report Key: 3747802
• MDR Text Key: 4470348
• Report Number: 1417411-2014-00004
• 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: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 01/06/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/22/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 003-40F
• Device Lot Number: 330137
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/06/2014
• 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