MAUDE Adverse Event Report: TELEFLEX 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 05/14/2014

Event Type  malfunction  

Event Description

The event is reported as: the distributor alleges that during incoming inspection a pinhole was found on the package.The distributor ((b)(4) distributor) reports a total of sixteen (16) packages with the alleged defect of pinhole.

Manufacturer Narrative

The device sample was not returned for eval at the time of this report.

• Brand Name: HUDSON SILENT HUMIDIFIER ADAPTOR 011
• Type of Device: HUMIDIFIER ADAPTOR
• Manufacturer (Section D): TELEFLEX MEDICAL; arlington heights IL
• Manufacturer (Section G): TELEFLEX; 900 west university dr.
• Manufacturer Contact: margie burton, rn ; po box 12600; durham, NC 27709 ; 9194334965
• MDR Report Key: 3950633
• MDR Text Key: 16447014
• Report Number: 1417411-2014-00043
• 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: 05/27/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/05/2014
• 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: K01311
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/27/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1