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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 170605-000120
Device Problem Break (1069)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/19/2022
Event Type  malfunction  
Manufacturer Narrative
Qn#(b)(4).The device investigation is pending.Teleflex will continue to monitor and trend related events.
 
Event Description
It was reported that the urologist claimed that the balloon of the foley was broken 1-2 days after being inserted to the patient.No patient harm reported.
 
Manufacturer Narrative
Qn#(b)(4).The batch card(s) for the complaint lot(s) was reviewed and passed qa inspection test.An actual sample was received for investigation.It was reported that balloon of the foley was broken 1-2 days after being inserted to the patient.Visual examination was conducted on the returned sample, and it was observed that the catheter was broken into 2 parts (funnel and shaft).Besides that , no other abnormalities observed.The balloon was still intact and in good condition.Both the catheter shaft and funnel were examined using dino-lite to analyze the damaged area and torn edges.Based on observation, the torn shaft surface was jagged and uneven.Review on the funnel portion reveals same cutting edges in which suggesting that the tube was once well attached to the funnel.Further investigation, the returned sample was inflated by using hypodermic needle on 12ml luer syringe and observed the balloon was able to inflate properly without having any issue.Attempt to deflate the balloon also observed no difficulties during removing the hypodermic needle from the lumen.Catheter broke may occur due to various reasons such as catheter was in contact with sharp or pointed object that may deteriorate the catheter.Nevertheless, as part of our initiative, positive released test was conducted at injection molding process.A maximum of 8 pieces of catheter from each batch were tested using weight load during start and stop of injection molding process.This is to test the bonding strength between the funnel and tube.Batches that pass this test are subjected for release.Besides that, in our current standard operating procedure, 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.Catheter with defective balloon will be culled out during this process.In summary, based on the investigation conducted, the balloon of the returned sample did not exhibit any sign of damage and failure to perform as intended.Therefore, this complaint could not be confirmed.
 
Event Description
It was reported that the urologist claimed that the balloon of the foley was broken 1-2 days after being inserted to the patient.No patient harm reported.
 
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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
jasmine brown
3015 carrington mill blvd
morrisville, NC 27560
9193614124
MDR Report Key15527210
MDR Text Key300995595
Report Number8040412-2022-00287
Device Sequence Number1
Product Code EZL
Combination Product (y/n)N
Reporter Country CodeHK
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 09/20/2022
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 Number170605-000120
Device Lot NumberKME20H2643
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/26/2022
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 09/20/2022
Initial Date FDA Received10/03/2022
Supplement Dates Manufacturer Received11/10/2022
Supplement Dates FDA Received11/14/2022
Was Device Evaluated by Manufacturer? No
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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