MAUDE Adverse Event Report: TELEFLEX MEDICAL RUSCH CATHETER PVC UNCOATED TIEMANN 14CH; UROLOGICAL CATHETER

Catalog Number	221800-000140
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Exsanguination (1841)
Date of Event	03/20/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that "per customer states patient said the catheter caused a lot of bleeding and patient lost a lot of blood which caused him to end up in the emergency room, where they inserted a foley that he is too leave in for 1 week.Patient has used this product before.No additional information provided".
Event or Problem Description
It was reported that "per customer states patient said the catheter caused a lot of bleeding and patient lost a lot of blood which caused him to end up in the emergency room, where they inserted a foley that he is too leave in for 1 week.Patient has used this product before.No additional information provided".
Additional Manufacturer Narrative
Qn (b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed, and no relevant findings were identified.Without the device to evaluate the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.Other remarks: n/a corrected data: n/a.

• Brand Name: RUSCH CATHETER PVC UNCOATED TIEMANN 14CH
• Common Device Name: UROLOGICAL CATHETER
• Manufacturer (Section D): TELEFLEX MEDICAL; athlone
• 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: 21104411
• Report Number: 8040412-2025-00021
• Device Sequence Number: 9171991
• Product Code: EZC
• UDI-Device Identifier: 04026704031825
• UDI-Public: (01)04026704031825(11)240625(17)270531(10)40E24F3470(21)
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K222279
• 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): 12/20/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: 221800-000140
• Device Lot Number: 40E24F3470
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/20/2024
• Supplement Date Received by Manufacturer: 02/06/2025
• Initial Report FDA Received Date: 01/08/2025
• Supplement Report FDA Received Date: 02/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/25/2024
• 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