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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
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TELEFLEX MEDICAL SDN. BHD. BRILLANT 2-W SILICONE FOLEY, CYLINDRICAL Back to Search Results
Catalog Number 171305-000160
Device Problem Fluid/Blood Leak (1250)
Patient Problem No Information (3190)
Event Date 12/31/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(4).The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.
 
Event Description
The report states: we faced several leakages of balloons involving urinary catheters (170605-000160 or 171305-000160 according to the sales representative.The balloons had to be re-inflated and the catheters had to be replaced more often that it should be.
 
Manufacturer Narrative
(b)(4).The device lot number was not provided; therefore a dhr review could not be conducted.No sample is available for the manufacturer to evaluate.Leak balloon could be due to several reasons.However, in the absence of returned sample and limited information available on this complaint, further investigation could not be conducted and therefore complaint is not confirmed.
 
Event Description
The report states: we faced several leakages of balloons involving urinary catheters (170605-000160 or 171305-000160 according to the sales representative.The balloons had to be re-inflated and the catheters had to be replaced more often that it should be.
 
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Brand Name
BRILLANT 2-W SILICONE FOLEY, CYLINDRICAL
Manufacturer (Section D)
TELEFLEX MEDICAL SDN. BHD.
perak, west malaysia
MDR Report Key9683056
MDR Text Key183755006
Report Number8040412-2020-00053
Device Sequence Number1
Product Code EZL
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Type of Report Initial,Followup
Report Date 01/13/2020
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 Number171305-000160
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 01/13/2020
Initial Date FDA Received02/07/2020
Supplement Dates Manufacturer Received02/27/2020
Supplement Dates FDA Received03/12/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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