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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, TIEMANN; CATHETER, RETENTION TYPE, BALLOON
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TELEFLEX MEDICAL SDN. BHD. BRILLANT 2-W SILICONE FOLEY, TIEMANN; CATHETER, RETENTION TYPE, BALLOON Back to Search Results
Catalog Number 171305-000180
Device Problem Fluid/Blood Leak (1250)
Patient Problem Insufficient Information (4580)
Event Date 01/11/2023
Event Type  malfunction  
Event Description
Reported issue: we faced issues with this device catalog #71305-000180.The balloons were inflated with 10 ml.Then we removed the catheters we found out that they are only filled with 5ml.When we remove the catheter and deflate the balloon, this 5 ml water inside the balloon are urine-like yellowish color.The balloon was fully deflated when the catheter was removed.No leak of the balloon identified but it is suspected that it was porous and that urine entered into the balloon then urine plus water leaked from the balloon.The syringe provided in the kit was used to inflate the balloon with the 10ml.
 
Manufacturer Narrative
(b)(4).The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.
 
Manufacturer Narrative
(b)(4).Four representative samples were returned for investigation.It was reported that balloon leaked.Visual examination was performed on the returned representative catheters and no material degradation or abnormalities observed.The entire components appeared to be in good condition.The catheters then inflated with 10ml of water.The balloon inflated normally and no difficulties during inflation.The sample then deflated using and empty syringe without any problem arise.Balloon able to be inflated without no leak issue.In our current standard operating procedure the products are subjected to 100% visual inspection and any defective raw balloon will be culled out before sent to the next process.Upon completion of assembly process, the finished catheter will again be subjected to 100% balloon inspection and 20 minutes leak test.The catheter with a defective balloon will be culled out.The returned sample did not exhibit any failure of balloon leak.Based on the investigation conducted, the balloons were still able to retain its inflated condition.Therefore, this complaint could not be confirmed as stated.
 
Event Description
Reported issue: we faced issues with this device catalog #71305-000180.The balloons were inflated with 10 ml.Then we removed the catheters we found out that they are only filled with 5ml.When we remove the catheter and deflate the balloon, this 5 ml water inside the balloon are urine-like yellowish color.The balloon was fully deflated when the catheter was removed.No leak of the balloon identified but it is suspected that it was porous and that urine entered into the balloon then urine plus water leaked from the balloon.The syringe provided in the kit was used to inflate the balloon with the 10ml.
 
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Brand Name
BRILLANT 2-W SILICONE FOLEY, TIEMANN
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
effie jefferson
3015 carrington mill blvd
morrisville 27560
9194332672
MDR Report Key16196163
MDR Text Key308966705
Report Number8040412-2023-00018
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,Company Representative
Reporter Occupation Risk Manager
Type of Report Initial,Followup
Report Date 01/11/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/18/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number171305-000180
Device Lot NumberKME21A1168
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? No
Date Manufacturer Received03/03/2023
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage A
Patient Sequence Number1
Treatment
NONE REPORTED; NONE REPORTED
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