MAUDE Adverse Event Report: TELEFLEX MEDICAL SDN. BHD. PURE GOLD TIEMANN 5-15ML PTFE STR H 18; CATHETER, UROLOGICAL

Catalog Number	318118
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/06/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported "the retention balloon failed to deflate when removal was attempted.The catheter shaft was cut and the catheterwas able to be removed after the sterilewater drained via the cut catheter shaft".No patient injury or consequence reported.The patient's current condition is reported as "fine".
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported "the retention balloon failed to deflate when removal was attempted.The catheter shaft was cut and the catheter was able to be removed after the sterile water drained via the cut catheter shaft".No patient injury or consequence reported.The patient's current condition is reported as "fine".
Additional Manufacturer Narrative
Qn# (b)(4).The sample was not returned to the manufacturer.The manufacturer reported: "visual.Functional, and dimensional inspection could not be conducted as no physical complaint sample was returned for investigation.A device history record review was performed, and no relevant findings were identified.Further investigation could not be conducted without the returned sample.Thus, this complaint could not be confirmed." teleflex will continue to monitor and trend for reports of this nature.

• Brand Name: PURE GOLD TIEMANN 5-15ML PTFE STR H 18
• Common Device Name: CATHETER, UROLOGICAL
• 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: mariah mackinnon ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 19005822
• Report Number: 8040412-2024-00098
• Device Sequence Number: 13125941
• Product Code: KOD
• UDI-Device Identifier: 04026704303113
• UDI-Public: 04026704303113
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 03/12/2024

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: 318118
• Device Lot Number: KMA22K0616
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/12/2024
• Supplement Date Received by Manufacturer: 04/30/2024
• Initial Report FDA Received Date: 03/29/2024
• Supplement Report FDA Received Date: 05/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/28/2022
• 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: Male