MAUDE Adverse Event Report: TELEFELX MEDICAL HUDSON SILENT HUMIDIFIER ADAPTOR 011

Catalog Number 000-11

Device Problem Tear, Rip or Hole in Device Packaging (2385)

Patient Problem No Patient Involvement (2645)

Event Date 01/24/2014

Event Type  malfunction  

Event Description

The event is reported as: a pin hole was detected on the package.The alleged issue was detected by the distributor (imj) during incoming inspection.(b)(4).

Manufacturer Narrative

A visual, functional and dimensional inspection of the product involved in the complaint could not be conducted since the product was not returned.A review of mfg 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 were acceptable.Post sterility and package integrity tests shows one non-conformance that may have an impact on the quality issue reported.Non-confirming 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 pin hole on package found at inspection on adaptor products.No sample available from the customer to investigate.Complaint not confirmed.Root cause unk.

• Brand Name: HUDSON SILENT HUMIDIFIER ADAPTOR 011
• Type of Device: HUMIDIFIER ADAPTOR
• Manufacturer (Section D): TELEFELX MEDICAL; arlington heights IL
• Manufacturer (Section G): TELEFLEX; 900 west university dr.; arlington heights IL 60004
• Manufacturer Contact: margie burton, rn ; po box 12600; durham, NC 27709 ; 9194334965
• MDR Report Key: 3843666
• MDR Text Key: 15127406
• Report Number: 1417411-2014-00014
• 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,Distributor
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 03/04/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 000-11
• Device Lot Number: F01311
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/04/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1