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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 170605-000160
Device Problems Inflation Problem (1310); Leak/Splash (1354)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/01/2021
Event Type  malfunction  
Event Description
Catheter inserted on (b)(6) 2021 morning.The same day in the evening during the care provided by a caregiver, the catheter ended in her hands, like self-expelled out of the patient.After observing the catheter, we noticed that the balloon was not inflated and seemed damaged; seems it had a hole.There were no clinical consequences for the patient.
 
Manufacturer Narrative
(b)(4).The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.
 
Event Description
Catheter inserted on (b)(6) 2021 morning.The same day in the evening during the care provided by a caregiver, the catheter ended in her hands, like self-expelled out of the patient.After observing the catheter, we noticed that the balloon was not inflated and seemed damaged; seems it had a hole.There were no clinical consequences for the patient.
 
Manufacturer Narrative
Qn#(b)(4).The device lot number was not provided; therefore , a dhr review could not be conducted.1 piece of actual sample was returned for investigation.Based on the complaint description, it was reported the balloon was not inflated and seem damaged (seemed it had a hole).Review on the returned sample noticed that the balloon was already burst.Further investigation was conducted by reviewing the balloon part under high magnification lens (dino lite) with 50x magnification on the actual sample.Based on picture 2, there were scratch and dented marks observed on the balloon surface of the sample.The presence of scratch marks may occur due to several reasons such as in contact with sharp object or pointed object during handling that render the balloon to burst.Other than that, it was mentioned by the customer that the balloon was pretested with a 20cc balloon inflation which are more than the capacity design for the 10cc balloon.In current standard operating procedure, according to 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, as per spm-a52-004 the finished catheter will be again subjected to 100% balloon inspection and 20 minutes leak test.Catheter with defective balloon will be culled out during this process.Based on the investigation conducted, burst balloon may have likely happened due to overinflation or it is in contact with sharp or pointed surface leaving scratch marks on the balloon surface.These scratch marks may propagate and lead to burst.Therefore, this complaint could not be confirmed.
 
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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 Key12983737
MDR Text Key283758676
Report Number8040412-2021-00336
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
Reporter Occupation Risk Manager
Type of Report Initial,Followup
Report Date 12/09/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/13/2021
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? Device Returned to Manufacturer
Date Returned to Manufacturer01/05/2022
Is the Reporter a Health Professional? No
Date Manufacturer Received01/21/2022
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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