MAUDE Adverse Event Report: TELEFLEX MEDICAL SDN. BHD. RUSCH GOLD LATEX 2W 5-15ML; CATHETER, UROLOGICAL

Catalog Number	180705240
Medical Device Problem Code	Pumping Problem (3016)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/26/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The sample was returned to the manufacturer for evaluation.The manufacturer reported: "one actual sample was returned for investiga tion.The returned catheter was inflated with 15ml of water using a luer tip syringe.The balloons inflated without any difficulties.No latex particle or other foreign particle can be seen within the balloon or inflation eye.The inflation eye was normal, and no collapse of the inflation lumen observed.Leaving the inflated balloon for 30 minutes and it showed no sign of leak on any part of the catheter.Deflation of the balloon by connecting empty luer tip syringe barrel to the valve was smooth and completed.Non-deflation could be occurred due to several reasons such as it was being bent or kinked during the usage, improper fixation of syringe to the valve or excessive pressure applied during deflation process.Besides that, clamping with hard object, heavy encrustation of salt deposits and the use of inflating fluids such as non-sterile water or saline also may lead to such problem.Furthermore, the balloon with low fill volume than the recommended tends to have the problem.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.Based on the analysis carried out of the returned sample, the catheter was fully functional upon deflation test conducted.The balloon was able to inflate and deflate without any problem.Reviewing the manufacturing process, no potential cause could have contributed to the problem.The defect related to functionality of the product will be culled out during inspection.Since there was no product di s-functionality issue observed based on reported failure, therefore this complaint could not be confirmed.The returned complaint device meets manufacturing release specification was met.The complaint was not confirmed, and the root cause was not determined." teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported that " balloom is crushing/pinching the foley".Additional information states that the catheter was removed urgently and replaced.The patient's current condition is reported as "good".

• Brand Name: RUSCH GOLD LATEX 2W 5-15ML
• Common Device Name: CATHETER, UROLOGICAL
• 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: taliah shabazz ; 3015 carrington mill blvd; morrisville 27560
• MDR Report Key: 20138016
• Report Number: 8040412-2024-00214
• Device Sequence Number: 19639900
• Product Code: EZL
• UDI-Device Identifier: 14026704302304
• UDI-Public: (01)14026704302304(11)221228(17)271128(10)KMA22M0334(21)
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/06/2024

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 Catalogue Number: 180705240
• Device Lot Number: KMA22M0334
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/12/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/06/2024
• Initial Report FDA Received Date: 09/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/28/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown