MAUDE Adverse Event Report: TELEFLEX MEDICAL SDN. BHD. RUSCH GOLD LATEX FOLEY, CYLINDRICAL,PAEDIATRIC; CATHETER, RETENTION TYPE, BALLOON

Catalog Number 180003-000080

Device Problem Deflation Problem (1149)

Patient Problem Insufficient Information (4580)

Event Date 12/24/2022

Event Type  malfunction  

Event Description

Reported event: non-deflation of the catheter.It was removed by bursting the balloon with a suprapubic puncture.The catheter has been in plase for 3 days.There was no injury.

Manufacturer Narrative

(b)(4).The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.

Manufacturer Narrative

(b)(4).The device was returned to the manufacturing site for investigation.The manufacturing site reports that a visual exam was performed and it was found that the device was not kinked; however, it was returned torn apart.It was also reported that "the balloon was popped, and a monofilament was inserted to check for any blockage at the inflation lumen.As result, there is no blockage as the monofilament can go through the lumen easily.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 condition of the returned sample, the complaint could not be confirmed and the probable cause could not be determined.Teleflex will continue to monitor and trend for reports of this nature.

Event Description

Reported event: non-deflation of the catheter.It was removed by bursting the balloon with a suprapubic puncture.The catheter has been in place for 3 days.There was no injury.

• Brand Name: RUSCH GOLD LATEX FOLEY, CYLINDRICAL,PAEDIATRIC
• 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: 16357602
• MDR Text Key: 309383376
• Report Number: 8040412-2023-00072
• Device Sequence Number: 1
• Product Code: EZL
• Combination Product (y/n): N
• Reporter Country Code: SN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 180003-000080
• Device Lot Number: 0124
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/26/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: NONE REPORTED.; NONE REPORTED.
• Patient Outcome(s): Required Intervention
• Patient Age: 8 YR
• Patient Sex: Male