MAUDE Adverse Event Report: TELEFLEX MEDICAL SDN. BHD. RUSCH BRILLANT 2-W SILICONE FOLEY CATHETER; CATHETER, RETENTION TYPE, BALLOON

Catalog Number 170605-000140

Device Problem Leak/Splash (1354)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/02/2022

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 air loss is observed when inflating the balloon.The problem is observed when introducing the probe into the male urethra and insuflating 1-3 ml in the balloon.By introducing contrast by the light of the probe it is dislocated from urethra.A deflated balloon is observed.

Event Description

It was reported that air loss is observed when inflating the balloon.The problem is observed when introducing the probe into the male urethra and insuflating 1-3 ml in the balloon.By introducing contrast by the light of the probe it is dislocated from urethra.A deflated balloon is observed.

Manufacturer Narrative

Qn#(b)(4).Complaint verification testing could not be performed as it was reported that the sample is not available for return.A device history record review was performed and no relevant findings were identified.The manufacturing site reports "leak balloon may happen due to several reasons such as being in contact with sharp object during use i.E.Contact with clamper, kidney dish/tray, overinflating or contact with contradict lubricants such as oil based antiseptic phenols or their derivatives, grease, petroleum jelly, petroleum spirit, paraffin or other relative's compounds.Balloon could also leak as a result of balloon had encounter bladder or kidney stone during use for patient with bladder or kidney stone history." the manufacturing site also reports that the products are subjected to 100% visual inspection and any defective raw balloon would be detected prior to the assembly process.Upon completion of the assembly process, the finished catheter would be again subject to 100% balloon inspection and a 20 minute leak test.Without the device to evaluate the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.

• Brand Name: RUSCH BRILLANT 2-W SILICONE FOLEY CATHETER
• 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: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9194332672
• MDR Report Key: 16061507
• MDR Text Key: 307623038
• Report Number: 8040412-2022-00352
• Device Sequence Number: 1
• Product Code: EZL
• Combination Product (y/n): N
• Reporter Country Code: SP
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date: 12/05/2022

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 Number: 170605-000140
• Device Lot Number: KME20K3224
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/05/2022
• Initial Date FDA Received: 12/28/2022
• Supplement Dates Manufacturer Received: 01/20/2023
• Supplement Dates FDA Received: 01/24/2023
• 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 Number: 1
• Treatment: NONE REPORTED; NONE REPORTED