MAUDE Adverse Event Report: TELEFLEX MEDICAL SDN. BHD. FLOCATH QUICK HYDROPHILIC STRAIGHT 14FR; CATHETER, URETHRAL

Catalog Number	220400140
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	Pain (1994)
Date of Event	09/23/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that "when using catheters customer notice it was rough on the edge, when he used the catheter, it caused pain and bleeding".At the time of this report, the customer has not responded to any requests for additional information.
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.
Event or Problem Description
It was reported that "when using catheters customer notice it was rough on the edge, when he used the catheter, it caused pain and bleeding".At the time of this report, the customer has not responded to any requests for additional information.

• Brand Name: FLOCATH QUICK HYDROPHILIC STRAIGHT 14FR
• Common Device Name: CATHETER, URETHRAL
• 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: 20559529
• Report Number: 8040412-2024-00249
• Device Sequence Number: 16919873
• Product Code: GBM
• UDI-Device Identifier: 04026704323883
• UDI-Public: (01)04026704323883(11)230530(17)280430(10)40E23E4393(21)
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K183461
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/02/2024

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
• Device Catalogue Number: 220400140
• Device Lot Number: 40E23E4393
• 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: 10/02/2024
• Supplement Date Received by Manufacturer: 12/27/2024
• Initial Report FDA Received Date: 10/29/2024
• Supplement Report FDA Received Date: 02/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/30/2023
• 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