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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX HUDSON 780-35 CIRCUIT W/ COLUMN; BREATHING CIRCUIT
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TELEFLEX HUDSON 780-35 CIRCUIT W/ COLUMN; BREATHING CIRCUIT Back to Search Results
Catalog Number 780-35KIT
Device Problems Thermal Decomposition of Device (1071); Disassembly (1168); Hole In Material (1293)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/03/2014
Event Type  malfunction  
Event Description
The event is reported as: the customer alleges that the transposed circuit had a hole from a burned area.No report of a pt injury or delay in treatment.
 
Manufacturer Narrative
A visual inspection of the product involved in the complaint was performed on the picture provided by the customer.It can be observed a damage (a hole) on one of the corrugated tubing as it is described on this customer complaint.No other issues were found.A dimensional and functional inspection of the product involved in the complaint could not be conducted since the product was not returned.The device history record (dhr) of batch number 021l1302324 that belongs to catalog number 780-35kit has been reviewed and no issues or discrepancies were found which could potentially relate 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 specs.Based on similar complaints a (b)(4) has been issued in order to review current production, to identify a root cause and implement corresponding corrective actions.The reported defect "limbs reversed" cannot be confirmed since the product was not returned but based on similar complaints a (b)(4) has been issued in order to review current production.
 
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Brand Name
HUDSON 780-35 CIRCUIT W/ COLUMN
Type of Device
BREATHING CIRCUIT
Manufacturer (Section D)
TELEFLEX
nuevo laredo, tamaulipas
MX 
Manufacturer Contact
margie burton, rn
po box 12600
durham, NC 27709
9194334965
MDR Report Key3909857
MDR Text Key22141387
Report Number3004365956-2014-00081
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
Remedial Action Other
Type of Report Initial
Report Date 02/03/2014
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 Number780-35KIT
Device Lot Number02L1302324
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 02/03/2014
Initial Date FDA Received02/26/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/01/2013
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
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