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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 Problems Defective Device (2588); No Flow (2991)
Patient Problems Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/22/2021
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
Catheter was placed during a supine surgery.The catheter was placed without any problems.The doctors noticed after some time that no urine was drained so the catheter was removed after 2 hours and a 3-lumen catheter was inserted.With the other catheter urine drained properly but a slight bleeding was noted which stopped soon.Additional information: the affected catheter was discarded.No patient injury occurred and there was no medical intervention required.The patient is fine.Lubricant used was instillagel, balloon was inflated with 10ml glycerine solution.
 
Manufacturer Narrative
(b)(4).The batch card(s) for the complaint lot(s) was reviewed and all passed qa inspection.1 actual sample was returned for investigation.Based on the complaint description, it was reported that the doctors noticed after some time that no urine was drained which suggested that there was non-drainage.Visual examination conducted on the returned sample showed no obvious defect or abnormality.There was no sign of kinking, clamp mark or collapse lumen observed throughout the shaft.Also, closer inspection at the drainage eye showed no sign of blockage.Investigation was initiated by allowing air through the drainage lumen to observe any blockage passage.However, there is no abnormality found during investigation (refer picture 2).Further investigation was conducted by inflating the balloon and tested again to check any blockage issue due to collapse lumen.Again, no sign of constriction or blockage was observed.In current standard operating procedure, 100% block test and water leak test will be performed after funnel injection molding process as per spm-a51-002.Defective catheter will be detected and culled out during this process.Based on the investigation conducted on the actual sample, no sign of lumen constriction or blockage was found.The drainage channel able to function as per intended.Therefore, this complaint could not be confirmed.
 
Event Description
Catheter was placed during a supine surgery.The catheter was placed without any problems.The doctors noticed after some time that no urine was drained so the catheter was removed after 2 hours and a 3-lumen catheter was inserted.With the other catheter urine drained properly but a slight bleeding was noted which stopped soon.Additional information: the affected catheter was discarded.No patient injury occurred and there was no medical intervention required.The patient is fine.Lubricant used was instillagel, balloon was inflated with 10ml glycerine solution.
 
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Brand Name
BRILLANT 2-W SILICONE FOLEY, CYLINDRICAL
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 Key12778940
MDR Text Key281393851
Report Number8040412-2021-00283
Device Sequence Number1
Product Code EZL
Combination Product (y/n)N
Reporter Country CodeGM
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 10/22/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/09/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number170605-000120
Device Lot Number20BG03
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/23/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/10/2021
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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