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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFELX HUDSON SILENT HUMIDIFIER ADAPTOR 011
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TELEFELX HUDSON SILENT HUMIDIFIER ADAPTOR 011 Back to Search Results
Catalog Number 000-11
Device Problem Tear, Rip or Hole in Device Packaging (2385)
Patient Problem No Patient Involvement (2645)
Event Date 07/08/2014
Event Type  malfunction  
Event Description
The event is reported as: during incoming inspection by the distributor (intermed (b)(4)), it was reported there was a pin hole in the package.There were a total of 15 packages with the alleged defect.
 
Manufacturer Narrative
A device history record (dhr) review was performed and there were no issues found that could relate to the reported complaint.The product was assembled and inspected according to specifications.The sample was not returned for evaluation, therefore, the complaint could not be confirmed.If the sample is received, a follow-up report will be submitted with the investigation results.
 
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Brand Name
HUDSON SILENT HUMIDIFIER ADAPTOR 011
Type of Device
HUMIDIFIER ADAPTOR
Manufacturer (Section D)
TELEFELX
research traiangle park NC
Manufacturer Contact
katharine tarpley, reg. affairs
p.o. box 12600
rtp, NC 27709
9194334854
MDR Report Key4066577
MDR Text Key18002497
Report Number1417411-2014-00059
Device Sequence Number1
Product Code BTT
Combination Product (y/n)N
Reporter Country CodeJA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Distributor
Reporter Occupation Not Applicable
Type of Report Initial
Report Date 07/27/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/08/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number000-11
Device Lot NumberK01311
Was Device Available for Evaluation? Yes
Date Manufacturer Received07/27/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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