MAUDE Adverse Event Report: TELEFLEX MEDICAL SDN. BHD. RUSCH GOLD 2W 5ML SIL STR H 14; CATHETER, UROLOGICAL

Catalog Number	180705140
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/03/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Other remarks: n/a.Corrected data: n/a.
Event or Problem Description
It was reported that "patient reports the balloon would not deflate for removal.Uses a new catheter every night.This has happened appx.3 months ago as well, but he did not report it-thought it was just a 1 time issue until it happened this time".At the time of this report, the customer has not returned our requests for additional information.If further information is received, the complaint file will be updated.See associated mdr #8040412-2024-00014.
Additional Manufacturer Narrative
Qn#(b)(4).Customer provided photos were provided to the manufacturer.However, the sample was not returned.The manufacturer reported: "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.However, without returned sample, the actual phenomenon which could lead to non-deflation could not be determined and associate it wit h any of the above-mentioned root cause." teleflex will continue to monitor and trend complaints of this nature.Other remarks: n/a.Corrected data: n/a.
Event or Problem Description
It was reported that "patient reports the balloon would not deflate for removal.Uses a new catheter every night.This has happened appx.3 months ago as well, but he did not report it-thought it was just a 1 time issue until it happened this time".At the time of this report, the customer has not returned our requests for additional information.If further information is received, the complaint file will be updated.See associated mdr #8040412-2024-00014.

• Brand Name: RUSCH GOLD 2W 5ML SIL STR H 14
• 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: mariah mackinnon ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 18495582
• Report Number: 8040412-2024-00013
• Device Sequence Number: 3554354
• Product Code: KOD
• UDI-Device Identifier: 14026704302205
• UDI-Public: 14026704302205
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/05/2024

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
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 180705140
• Device Lot Number: KMA22J1182
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/05/2024
• Supplement Date Received by Manufacturer: 04/09/2024
• Initial Report FDA Received Date: 01/11/2024
• Supplement Report FDA Received Date: 04/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/28/2022
• 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: Male