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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 Deflation Problem (1149)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/20/2022
Event Type  malfunction  
Event Description
Reported issue: nurses reported that when they aspirate the contents of the balloon for deflation, after removing the catheter, they observed liquid in the balloon is remaining.They describe the balloon as weird.Consequence, obligation to insert another catheter.Urinary leaks at the meatus are happening recurrently with different sizes was also reported in a different event report.
 
Manufacturer Narrative
Qn#(b)(4).The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.
 
Event Description
Reported issue: nurses reported that when they aspirate the contents of the balloon for deflation, after removing the catheter, they observed liquid in the balloon is remaining.They describe the balloon as weird.Consequence, obligation to insert another catheter.Urinary leaks at the meatus are happening recurrently with different sizes was also reported in a different event report.
 
Manufacturer Narrative
Qn# (b)(4).No alleged sample was returned for investigation.Hence, investigation shall be conducted based on document review.According to the complaint description, it was reported that: nurses reported that when they aspirate the contents of the balloon (for deflation), after removing the catheter, they observed that liquid in the balloon is remaining.They describe the balloon as "weird".According to the ifu d60514 in case of non-inflatable balloons, cut the catheter shaft at the bifurcation of perforate the balloon according to established procedures.Non deflation could also happen due to over inflation of the balloon where the excessive aspiration can collapse inflation lumen and asymmetrical condition of the balloon due to overinflation which may result in occlusion of the inflation lumen eye during deflation process.However, since no actual or representative sample returned, the asymmetry ratio could not be measured where the acceptable limit for balloon asymmetry is based on 1:3 per internal requirement of qasa001: quality assurance inspection criteria for all silicone foleys and special products.In current standard operating procedure as per spm-a51-003, the products are subjected to 100% visual inspection and any defective raw balloon will be culled out before sent to the next process.Upon completion of assembly process, the finished catheter will be again subjected to 100% balloon inspection and 20 minutes leak test.The catheter with defective balloon will be culled out.According to the description of the complaint, there catheter is not fully deflated.There are several potential root causes that may cause the non-inflation.However, without the presence of the physical sample, the root cause could not be identified.Therefore, this complaint could not be confirmed.
 
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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
effie jefferson
3015 carrington mill blvd
morrisville 27560
9194332672
MDR Report Key16086581
MDR Text Key307623385
Report Number8040412-2023-00001
Device Sequence Number1
Product Code EZL
Combination Product (y/n)N
Reporter Country CodeFR
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,User Facility,Company Representative
Reporter Occupation Nurse
Type of Report Initial,Followup
Report Date 12/20/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/03/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number170605-000160
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/07/2023
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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