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

Catalog Number	220400140
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	Urinary Tract Infection (2120)
Date of Event	07/20/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).

• 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: azhwan barazenda ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 50212697
• Report Number: 8040412-2026-00131
• Device Sequence Number: 21334503
• Product Code: GBM
• UDI-Device Identifier: 14026704945402
• 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: Consumer,Distributor
• Type of Report: Initial,Followup
• Report Date (Section B): 07/22/2026

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
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 220400140
• Device Lot Number: 40E25M2032
• 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: 07/22/2026
• Supplement Date Received by Manufacturer: 09/08/2026
• Initial Report FDA Received Date: 08/11/2026
• Supplement Report FDA Received Date: 09/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/12/2025
• 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: None reported.
• Patient Sex: Unknown