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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX MEDICAL SDN. BHD. BRILLANT 2-W SILICONE FOLEY, CYLINDRICAL; CATHETER, RETENTION TYPE, BALLOON
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TELEFLEX MEDICAL SDN. BHD. BRILLANT 2-W SILICONE FOLEY, CYLINDRICAL; CATHETER, RETENTION TYPE, BALLOON Back to Search Results
Catalog Number 170605-000160
Device Problem Fluid/Blood Leak (1250)
Patient Problem Insufficient Information (4580)
Event Date 10/12/2022
Event Type  malfunction  
Event Description
It was reported that during use, we observed urine leaks at the level of the urethral meatus.The catheter seems to be well positioned and the balloon seems to be properly inflated.It happened with catheters size 16 and 18.No pre-testing was done.The balloon was inflated with 10cc of sterile water.There was no report of encrustation, or bladder stones.The gel used was listed as kly5.The catheters were removed and changed.The patient's condition was reported as fine.
 
Manufacturer Narrative
(b)(4).The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.
 
Event Description
It was reported that during use, we observed urine leaks at the level of the urethral meatus.The catheter seems to be well positioned and the balloon seems to be properly inflated.It happened with catheters size 16 and 18.No pre-testing was done.The balloon was inflated with 10cc of sterile water.There was no report of encrustation, or bladder stones.The gel used was listed as kly5.The catheters were removed and changed.The patient's condition was reported as fine.
 
Manufacturer Narrative
(b)(4).The device lot number was not provided; therefore a dhr review could not be conducted.There was no complaint sample returned for investigation.Therefore, no physical assessment could be conducted.Due to no actual sample returned for this complaint, any further investigation was not possible.Moreover, lot number is not provided, hence dhr review could not be carried out.Therefore, this complaint could not be confirmed.
 
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Brand Name
BRILLANT 2-W SILICONE FOLEY, CYLINDRICAL
Type of Device
CATHETER, RETENTION TYPE, BALLOON
Manufacturer (Section D)
TELEFLEX MEDICAL SDN. BHD.
perak, west malaysia
Manufacturer (Section G)
TELEFLEX MEDICAL SDN. BHD.
lot no : pt2577 jalen perusahaan
4 kamunting industrial estate
perak, west malaysia 34600
MY   34600
Manufacturer Contact
jasmine brown
3015 carrington mill blvd
morrisville, NC 27560
9193614124
MDR Report Key15694864
MDR Text Key303238912
Report Number8040412-2022-00307
Device Sequence Number1
Product Code EZL
Combination Product (y/n)N
Reporter Country CodeFR
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional
Reporter Occupation Risk Manager
Type of Report Initial,Followup
Report Date 10/12/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/29/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number170605-000160
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received11/30/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage A
Patient Sequence Number1
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