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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX MEDICAL 6FR 100% SILICONE FOLEY; FOLEY CATHETER
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TELEFLEX MEDICAL 6FR 100% SILICONE FOLEY; FOLEY CATHETER Back to Search Results
Catalog Number 170003060
Device Problem Break (1069)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/18/2015
Event Type  malfunction  
Event Description
Alleged event: the catheter was pre-tested per facility protocol without issue but a day after insertion, the catheter broke at the juncture of the lumen and lumen hub.The patient's condition was reported as fine.
 
Manufacturer Narrative
(b)(4).The device sample has been returned to the manufacturer however the investigation report has not been submitted at the time of this report.The manufacturer will continue to monitor and trend related events.
 
Manufacturer Narrative
(b)(4).The device history records (lot 12ce14, 11ge32 & 121e40) were reviewed and no issue that could have contributed to the reported failure was noted.The device was manufactured according to release specification.From visual observation on the representative samples, no issue was found.All components were intact and in good condition.Based on the report statement, a catheter was found broken at the junction of the tube, a day after insertion.To confirm device is functioning well, funnel detachment test was conducted to determine the bonding strength between funnel and shaft of the representative sample.In addition, (b)(4) pieces of production samples inclusive of representative samples were picked for funnel detachment test.Based on the findings, all tested samples met the minimum requirement of 7.5n and no other findings within the product, which could have contributed from manufacturing processes.In the absence of the actual samples, we could not conduct further investigation to associate the nature of the failure with any manufacturing inadequacy.Therefore this complaint is not confirmed.
 
Event Description
Alleged event: the catheter was pre-tested per facility protocol without issue but a day after insertion, the catheter broke at the juncture of the lumen and lumen hub.The patient's condition was reported as fine.
 
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Brand Name
6FR 100% SILICONE FOLEY
Type of Device
FOLEY CATHETER
Manufacturer (Section D)
TELEFLEX MEDICAL
perak, west malaysia
Manufacturer (Section G)
TELEFLEX MEDICAL
po box 28, kamunting industrial estate
perak, west malaysia 34600
MY   34600
Manufacturer Contact
jasmine brown
3015 carrington mill blvd
morrisville, NC 27560
9193614124
MDR Report Key4912570
MDR Text Key6050479
Report Number8040412-2015-00148
Device Sequence Number1
Product Code FGH
Combination Product (y/n)N
Reporter Country CodeCA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,User Facility,Company Representative,company representati
Reporter Occupation Other
Type of Report Initial
Report Date 06/18/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/14/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue Number170003060
Device Lot Number12CE14
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/21/2015
Is the Reporter a Health Professional? No
Date Manufacturer Received08/18/2015
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? Yes
Patient Sequence Number1
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