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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX MEDICAL SDN. BHD. BRILLANT SILICONE FOLEY, CYL. PAEDIATRIC
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TELEFLEX MEDICAL SDN. BHD. BRILLANT SILICONE FOLEY, CYL. PAEDIATRIC Back to Search Results
Catalog Number 170003-000060
Device Problem No Flow (2991)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/01/2021
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
On july 1st, the rusch brillant balloon catheter was placed on the little girl.Unfortunately, the urine ran out next to the catheter and not through the catheter.The nurse tried to flush the catheter which unfortunately did not work.The catheter was removed.The patient suffered off a urinary retention which was the reason why she had a catheter placed for 12 hours.After the catheter was removed, she was able to urinate herself again.The patient is fine and there were no other problems.The catheter was checked before insertion.Ky jelly lubricant was used.The filling medium was aqua dest 1.5ml.
 
Manufacturer Narrative
Qn#(b)(4).The batch card(s) for the complaint lot(s) was reviewed and all passed qa inspection.1 actual sample returned for investigation.Based on the complaint description, it was reported that bladder catheter did not drain urine.The urine run next to the catheter.Attempt to flush the catheter failed so the catheter was removed.After removal of the catheter, it was also very difficult to flush the catheter.This information might suggest that the catheter had blocked.Visual inspection of the catheter did not show any damages or abnormality found.The catheter was then inflated with 1.5 ml of water by using 10ml luer tip syringe and noticed that balloon could be inflated without any difficulties encountered.No silicone particle or other foreign particle seen within the balloon.Closer observation on the drainage eyes of the catheter did not show any abnormality.The drainage eyes were of normal size and shape.No silicone slugs or particle found that could occluded the drainage lumen observed.Leaving the inflated balloon for 30 minutes showed no sign of leak on any part of the catheters.Deflation of the balloons by connecting empty luer tip syringe barrel to the valve was smooth, spontaneous and complete.Balloon able to stay inflated and deflated smoothly.No blocked or leak was observed throughout the catheter.In current standard operating procedure, the product will undergo several stages of inspection.Block test was performed after funnel injection molding process as per spm-a51-002.Defective catheter will be detected and culled out during this process.Final 100% visual inspection was also conducted on the catheter as per spm-a52-004 and product will be released upon passing this inspection.Based on the analysis carried out, the catheter was fully functional upon completion of inflation and deflation tests.The balloon was able to inflate and deflate without any problem.There was no blockage on drainage line as water could pass through drainage lumen when water was introduced.Since there was no product dis-functionality issue observed based on reported failure, therefore this complaint could not be confirmed.
 
Event Description
On july 1st, the rusch brillant balloon catheter was placed on the little girl.Unfortunately, the urine ran out next to the catheter and not through the catheter.The nurse tried to flush the catheter which unfortunately did not work.The catheter was removed.The patient suffered off a urinary retention which was the reason why she had a catheter placed for 12 hours.After the catheter was removed, she was able to urinate herself again.The patient is fine and there were no other problems.The catheter was checked before insertion.Ky jelly lubricant was used.The filling medium was aqua dest 1.5ml.
 
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Brand Name
BRILLANT SILICONE FOLEY, CYL. PAEDIATRIC
Manufacturer (Section D)
TELEFLEX MEDICAL SDN. BHD.
perak, west malaysia
MDR Report Key12126966
MDR Text Key262621734
Report Number8040412-2021-00201
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 07/02/2021
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 Number170003-000060
Device Lot Number20DG09
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/21/2021
Initial Date Manufacturer Received 07/02/2021
Initial Date FDA Received07/07/2021
Supplement Dates Manufacturer Received08/17/2021
Supplement Dates FDA Received08/17/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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