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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 Deflation Problem (1149)
Patient Problems Pain (1994); Blood Loss (2597); No Information (3190)
Event Date 09/24/2019
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 in order to remove the catheter the nurse deflated the balloon and 1.5ml of water was removed from the balloon.After removing the catheter a few centimeters there was an important resistance.The young female patient was in a lot of pain.The device had an important lump on the balloon.The doctor managed to remove the catheter but there was blood at the end of the catheter.
 
Event Description
It was reported that in order to remove the catheter the nurse deflated the balloon and 1.5ml of water was removed from the balloon.After removing the catheter a few centimeters there was an important resistance.The young female patient was in a lot of pain.The device had an important lump on the balloon.The doctor managed to remove the catheter but there was blood at the end of the catheter.
 
Manufacturer Narrative
Qn#(b)(4).The device lot number was not provided; therefore , a dhr review could not be conducted.One actual sample was returned for investigation.Based on the complaint statement, it was reported that the user wanted to remove the device , but the balloon could not be deflated.To verify the accessibility to the balloon deflation, the actual sample was inflated with l.5ml of water using normal syringe and showed no issue to stay inflated.The sample was then subjected to deflation testing using the same method.Once again, the sample is able to deflate completely without having any difficulty and no significant lump that cause a resistance during removal.Non-deflation could be due to several reasons such as improper fixation of syringe to the valve, faulty valve and blockage of inflation lumen.In a standard practice, an empty syringe without plunger is also recommended to be used to drain off the fluid by gravity and avoid creation of vacuum effect and ease deflation process.Besides that , based on the ifu, it was advice to cut the shaft near the entry site as to allow the liquid to flow out of the balloon if the valve fails to deflate the balloon.In our current standard operating procedure, the products are subjected to 100% visual inspection and any defective raw balloon will be discarded before sent to the next process.Upon completion of assembly process, the finished catheter will be again subjected to 100% balloon inspection, 20 minutes leak test and 100% deflation process.Catheter with defective balloon will be culled out during this process.Non-deflation balloon may due to several reasons.However, after investigation there was no deflation issue encountered during testing.Therefore, this complaint could not be confirmed.
 
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Brand Name
BRILLANT SILICONE FOLEY, CYL. PAEDIATRIC
Manufacturer (Section D)
TELEFLEX MEDICAL SDN. BHD.
perak, west malaysia
MDR Report Key9192345
MDR Text Key168030424
Report Number8040412-2019-00299
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,u
Type of Report Initial,Followup
Report Date 09/26/2019
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 NumberUNKNOWN
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received 09/26/2019
Initial Date FDA Received10/15/2019
Supplement Dates Manufacturer Received11/19/2019
Supplement Dates FDA Received11/26/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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