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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX HUDSON BREATHING CIRCUIT, ADLT, SGL LIMB W/HTD W
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TELEFLEX HUDSON BREATHING CIRCUIT, ADLT, SGL LIMB W/HTD W Back to Search Results
Catalog Number 780-96
Device Problems Disconnection (1171); Fitting Problem (2183)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/13/2014
Event Type  malfunction  
Event Description
The event is reported as: the customer alleges the temperature probe port on the circuit is too large of an opening fro the temperature probe.Therefore, the temperature probe does not stay in the circuit.
 
Manufacturer Narrative
Patient identifier: it is unk if the device was in use on a pt when the alleged issue occurred.The device sample was received by the manufacturer, but the investigation is incomplete at the time of this report.The device history record (dhr) of batch number 02a1401331 has been received and no issues or discrepancies were found related to this complaint.No non conformance reports were originated for the lot in question that can be associated to the complaint reported.The dhr shows that the product was assembled and inspected according to our specifications.
 
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Brand Name
HUDSON BREATHING CIRCUIT, ADLT, SGL LIMB W/HTD W
Type of Device
BREATHING CIRCUIT
Manufacturer (Section D)
TELEFLEX
nuevo laredo
MX 
Manufacturer Contact
margie burton, rn
p.o. box 12600
durham, NC 27709
9194334965
MDR Report Key3847686
MDR Text Key4685027
Report Number3004365956-2014-00130
Device Sequence Number1
Product Code CAG
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 02/25/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number780-96
Device Lot Number02A1401331
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer03/05/2014
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 02/25/2014
Initial Date FDA Received03/18/2014
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/01/2014
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
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