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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX HUDSON PEDIATRIC BREATHING CIRCUIT, 30"; ANESTHESIA BREATHING CIRCUIT
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TELEFLEX HUDSON PEDIATRIC BREATHING CIRCUIT, 30"; ANESTHESIA BREATHING CIRCUIT Back to Search Results
Catalog Number 353801
Device Problem Crack (1135)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/28/2014
Event Type  malfunction  
Event Description
The complaint is reported as: the end of the circuit cracked during use.No patient injury was reported.
 
Manufacturer Narrative
The device history record of batch number 02h1301128 was reviewed and there were no issues or discrepancies found that could relate to the reported complaint.No non-conformance reports were originated for the lot in question.The dhr shows that the product was assembled and inspected according to specifications.The sample was received, however, the investigation results were not complete at the time of this report.A follow-up report will be submitted upon completion of the investigation.
 
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Brand Name
HUDSON PEDIATRIC BREATHING CIRCUIT, 30"
Type of Device
ANESTHESIA BREATHING CIRCUIT
Manufacturer (Section D)
TELEFLEX
nuevo laredo
MX 
Manufacturer Contact
katharine tarpley
po box 12600
durham, NC 27709
9194334854
MDR Report Key3994014
MDR Text Key4823235
Report Number3004365956-2014-00277
Device Sequence Number1
Product Code OFP
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,User Facility,Company Representative,Distributor
Reporter Occupation Not Applicable
Type of Report Initial
Report Date 07/10/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/24/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number353801
Device Lot Number02H1301128
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer07/17/2014
Date Manufacturer Received07/10/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/01/2013
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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