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

Catalog Number	180705240
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/11/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Qn# (b)(4).
Event or Problem Description
It was reported that: "the customer advised that the balloon would not deflate.This occurred during two different procedures and one of the two procedures was so bad that the patient had to be taken to surgery as a result".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.
Additional Manufacturer Narrative
(b)(4).The representative samples were returned to the manufacturer for evaluation.The manufacturer reported: visual inspection conducted on the returned samples and showed that there was no sign of kinking, clamp mark or collapse lumen observed throughout the shaft.All catheters were inflated with 10ml 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.The device history record for lot kma22m0334 was reviewed and no issue that could have contributed to the reported failure was noted.The device was manufactured according to release specification.Corrective actions cannot be established since complaint is not verified as manufacturing related issue.Device has undergone 100% visual inspection, inflation and deflation test as part of device release criteria prior release to the market.Based on the analysis carried out on the returned samples, all catheters were fully functional upon deflation test conducted.The balloon was able to inflate and deflate without any problem.The defect related to functionality of the product will be culled out during inspection.Since there was no product dysfunctionality issue observed based on reported failure, therefore this complaint could not be confirmed and not verified.
Event or Problem Description
It was reported that: "the customer advised that the balloon would not deflate.This occurred during two different procedures and one of the two procedures was so bad that the patient had to be taken to surgery as a result".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.

• Brand Name: RUSCH GOLD LATEX 2W 5-15ML
• Common Device Name: FOLEY CATHETER
• 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: sachin sony ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 21333604
• Report Number: 8040412-2025-00030
• Device Sequence Number: 14415359
• 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: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K232469
• 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,Followup
• Report Date (Section B): 01/16/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: 180705240
• Device Lot Number: KMA22M0334
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/16/2025
• Supplement Date Received by Manufacturer: 03/13/2025
• Initial Report FDA Received Date: 02/07/2025
• Supplement Report FDA Received Date: 03/26/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: N/A.; N/A.
• Patient Sex: Unknown