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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 Break (1069)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/19/2022
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
Reported issue: the urologist claimed that the balloon of the foley was broken 1-2 days after being inserted into the patient.There was no injury reported.
 
Event Description
Reported issue: the urologist claimed that the balloon of the foley was broken 1-2 days after being inserted into the patient.There was no injury reported.
 
Manufacturer Narrative
(b)(4).No actual or representative sample was returned for investigation.Based on the complaint statement "the balloon of the foley was broken 1-2 days after being inserted to the patient", the catheter balloon could have been burst during use.Review of the photo provided showed on all parts of the catheter are still in-tact.Balloon was in deflated condition.A part of the catheter, especially the proximal side appeared slightly brownish/yellowish when compared to the distal part of the catheter which is transparent.When the photo was closely reviewed, it was unable to reveal its actual condition.The balloon is still in-tact to the shaft and no obvious defect was able to be observed.In the absence of actual sample, the burst on the balloon could not be observed clearly.Burst balloon may happen due to several reasons such as being in contact with sharp object during use i.E., contact with clamper, kidney dish/ tray, overinflating or contact with contradict lubricants such as oil based antiseptic phenols or their derivatives, grease, petroleum jelly, petroleum spirit, paraffin or other relative's compounds.Balloon could also burst as a result of balloon had come in contact with bladder or kidney stone during use for patient with bladder or kidney stone history.In the absence of any actual or representative sample for investigation, further investigation could not be conducted to identify the actual root cause of this reported failure.Moreover, based on the photo provided by the complainant, it could not be observed clearly that the balloon burst.Without the device to evaluate, the complaint could not be confirmed, and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.
 
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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
bryanna connelly
3015 carrington mill blvd
morrisville 27560
9194332672
MDR Report Key15825388
MDR Text Key304805348
Report Number8040412-2022-00322
Device Sequence Number1
Product Code EZL
Combination Product (y/n)N
Reporter Country CodeHK
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 10/28/2022
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 Number170605-000160
Device Lot NumberKME21D1877
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 10/28/2022
Initial Date FDA Received11/18/2022
Supplement Dates Manufacturer Received12/15/2022
Supplement Dates FDA Received12/15/2022
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
Treatment
NONE REPORTED; NONE REPORTED
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