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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 170605-000120
Device Problem Burst Container or Vessel (1074)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/23/2020
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
It was reported that the balloon catheter was inserted, the balloon was inflated with 8ml aqua dest.500 ml of urine drained.Then suddenly the device slips out.It was visible that the balloon was defective.The indwelling catheter had to be inserted again; uncomfortable for the patient.
 
Manufacturer Narrative
Qn# (b)(4).The batch card(s) for the complaint lot(s) was reviewed and passed qa inspection.There was no complaint sample returned for investigation.Therefore, no physical assessment can be conducted.Due to no actual sample returned for this investigation, any further investigation was not possible.Therefore, this complaint could not be confirmed.
 
Event Description
It was reported that the balloon catheter was inserted, the balloon was inflated with 8ml aqua dest.500 ml of urine drained.Then suddenly the device slips out.It was visible that the balloon was defective.The indwelling catheter had to be inserted again; uncomfortable for the patient.
 
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Brand Name
BRILLANT 2-W SILICONE FOLEY, CYLINDRICAL
Manufacturer (Section D)
TELEFLEX MEDICAL SDN. BHD.
perak, west malaysia
MDR Report Key10941785
MDR Text Key251562494
Report Number8040412-2020-00256
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 11/26/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/03/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date12/28/2023
Device Catalogue Number170605-000120
Device Lot Number19AE02
Was Device Available for Evaluation? No
Date Manufacturer Received12/17/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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