MAUDE Adverse Event Report: TELEFLEX MEDICAL SDN. BHD. PURE GOLD TIEMANN 30-50ML PTFE STR H 16; CATHETER, UROLOGICAL

Catalog Number	318316
Medical Device Problem Code	Failure to Deflate (4060)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/18/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that "the 16fr was inserted into the patient 2 days before and he returned back to the clinic for follow up.When they attempted to remove the catheter the balloon would not deflate.The urologist instilled mineral oil." the catheter was successfully removed.No report of patient harm or injury.
Event or Problem Description
It was reported that "the 16fr was inserted into the patient 2 days before and he returned back to the clinic for follow up.When they attempted to remove the catheter the balloon would not deflate.The urologist instilled mineral oil." the catheter was successfully removed.No report of patient harm or injury.
Additional Manufacturer Narrative
(b)(4).The sample was returned and sent to the manufacturing site for investigation.The manufacturing site reports "visual examination on the catheter showed that there was blood residue at funnel joint area.The shaft also has been cut at several places including inflation funnel.Other than that, no sign of kinking, clamp mark or collapse lumen observed throughout the shaft.Since the inflation lumen has been cut, inflation and deflation test could not be conducted.Process with investigation, the balloon was cut to observe the inflation eye condition and noticed the eye was normal without any foreign matter or collapsed.Then, the monofilament was inserted through the inflation lumen from and no collapsed or blockage lumen observed.The funnel area was cut to test the valve functionality.The valve was connected to luer tip syringe and noticed it can be function as normal." the manufacturer also reports "based on the investigation, since the shaft has been cut, inflation and deflation could not be conducted.However, there was no foreign matter or collapsed observed in inflation eye, no collapsed or blockage through the inflation lumen and the valve can be function as normal.Reviewing the manufacturing process, no potential cause could have contributed to the problem.All products were subjected for 100% inspection of leak test, inflation and deflation test.The defect related to functionality of the product will be culled out during inspection.Therefore, this complaint is not confirmed." other remarks: n/a corrected data: n/a.

• Brand Name: PURE GOLD TIEMANN 30-50ML PTFE STR H 16
• 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: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 17433962
• Report Number: 8040412-2023-00314
• Device Sequence Number: 15681920
• Product Code: KOD
• UDI-Device Identifier: 04026704303175
• UDI-Public: 04026704303175
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/13/2023

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: Health Professional
• Device Catalogue Number: 318316
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/12/2023
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/13/2023
• Supplement Date Received by Manufacturer: 09/01/2023
• Initial Report FDA Received Date: 08/01/2023
• Supplement Report FDA Received Date: 09/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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