MAUDE Adverse Event Report: TELEFLEX MEDICAL SDN. BHD. FOLEY SILICONE 2W 1.5ML; CATHETER, RETENTION TYPE, BALL

Catalog Number	170003060
Medical Device Problem Code	Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/06/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn# (b)(4).
Event or Problem Description
It was reported that "rusch pediatric foley 3170003060 6fr, was being used for a vcug procedure when the tech injected the contrast media the catheter had a hole about 2 inches from the outer connection, it caused difficulty injecting the contrast, the radiologist declined to change it and presumably obtained the images needed.The catheter was inadvertently thrown out".
Event or Problem Description
It was reported that "rusch pediatric foley 3170003060 6fr, was being used for a vcug procedure when the tech injected the contrast media the catheter had a hole about 2 inches from the outer connection, it caused difficulty injecting the contrast, the radiologist declined to change it and presumably obtained the images needed.The catheter was inadvertently thrown out".
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.

• Brand Name: FOLEY SILICONE 2W 1.5ML
• Common Device Name: CATHETER, RETENTION TYPE, BALL
• 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: 20892419
• Report Number: 8040412-2024-00276
• Device Sequence Number: 12995266
• Product Code: EZL
• UDI-Device Identifier: 04026704307968
• UDI-Public: (01)04026704307968(11)240608(17)290531(10)40E24F1291(21)
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K972184
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/13/2024

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: 170003060
• Device Lot Number: 40E24F1291
• 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: 11/13/2024
• Supplement Date Received by Manufacturer: 01/23/2025
• Initial Report FDA Received Date: 12/10/2024
• Supplement Report FDA Received Date: 02/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/08/2024
• 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