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

Catalog Number	180705240
Medical Device Problem Code	Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/18/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported "the customer advised that the balloon would not deflate.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 sample was returned to the manufacturer for evaluation.The manufacturer reported: visual inspection conducted on the returned representative samples and showed that there was no sign of kinking, clamp mark or collapse lumen observed throughout the shafts.The samples are meeting the manufacturing released specifications.The catheters were 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 was performed by connecting empty luer tip syringe barrel to the valve.Deflation was smooth and drained completely.Balloon on the catheter were inspected, and all are in good conditions.The device history record for lot kma22e1204 was reviewed and no issue that could have contributed to the reported failure was noted.The device was manufactured according to release specification.Based on the analysis carried out on the representative sample, the catheter was fully functional upon deflation test conducted.The balloon was able to inflate and deflate completely 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 dis-functionality issue observed based on reported failure, therefore this complaint could not be confirmed or verified as manufacturing related issue.
Event or Problem Description
It was reported "the customer advised that the balloon would not deflate.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: 21560482
• Report Number: 8040412-2025-00066
• Device Sequence Number: 17250987
• Product Code: EZL
• UDI-Device Identifier: 14026704302304
• UDI-Public: (01)14026704302304(11)220528(17)270428(10)KMA22E1204(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): 02/12/2025

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: KMA22E1204
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/04/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/12/2025
• Supplement Date Received by Manufacturer: 03/13/2025
• Initial Report FDA Received Date: 03/10/2025
• Supplement Report FDA Received Date: 04/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/28/2022
• 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