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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX HUDSON BREATHING CIRCUIT, ANES, PED, 1.5 W/EXT H; ANESTHESIA CIRCUIT
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TELEFLEX HUDSON BREATHING CIRCUIT, ANES, PED, 1.5 W/EXT H; ANESTHESIA CIRCUIT Back to Search Results
Catalog Number 313901
Device Problem Crack (1135)
Patient Problem No Patient Involvement (2645)
Event Date 05/21/2014
Event Type  malfunction  
Event Description
The event is reported as: the customer alleges that prior to use, a small crack on one of the ends of the circuit was discovered.
 
Manufacturer Narrative
Two (2) pictures of a section of the product catalog number 313901 (breathing circuit, anes, ped, 1.5m w/ext h) were received for analysis.They were visually inspected finding a crack in the corrugated tubing p/n 10669-05 (corrugated tubing, 15x 22 mm, 60) as is described on the complaint description, this component is purchased from (b)(4) supplier.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 02g1300088 has been reviewed 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 specs.The customer complaint as confirmed based on the visual inspection of the received pictures, because it was detected a crack on the corrugated tubing p/n 10669-05 (corrugated tubing, 15 x 22 mm, 60), at present time it is not possible to determine where the issue reported occurred, since this condition if 100% tested at production line on tp-0145 (leak test).However the current inventory that is in nl factory of p/n 10669-05 (corrugated tubing, 15 x 22 mm, 60) related to this complaint notification was inspected by the defect of "cracks" as it is described on this customer description, and no issues were detected.A notification of customer complaint was sent to the supplier of this component (b)(4).
 
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Brand Name
HUDSON BREATHING CIRCUIT, ANES, PED, 1.5 W/EXT H
Type of Device
ANESTHESIA CIRCUIT
Manufacturer (Section D)
TELEFLEX
nuevo laredo
MX 
Manufacturer Contact
margie burton, rn, regulatory af
p.o. box 12600
durham, NC 27709
9194334965
MDR Report Key3998805
MDR Text Key4777432
Report Number3004365956-2014-00220
Device Sequence Number1
Product Code OFP
Combination Product (y/n)N
Reporter Country CodeRS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,User Facility,Company Representative
Reporter Occupation Not Applicable
Type of Report Initial
Report Date 05/23/2011
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/06/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number313901
Device Lot Number02G1300088
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Date Manufacturer Received05/23/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/01/2013
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
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