MAUDE Adverse Event Report: TELEFLEX MEDICAL SDN. BHD. PURE GOLD TIEMANN 5-15ML PTFE STR H 16; CATHETER, UROLOGICAL

Model Number	IPN051269
Medical Device Problem Code	No Flow (2991)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.
Event or Problem Description
Foley was clogged and would not void.Patient had to remove and use another.No patient harm.
Event or Problem Description
Foley was clogged and would not void.Patient had to remove and use another.No patient harm.
Additional Manufacturer Narrative
Qn# (b)(4).The device lot number was not provided; therefore a dhr review could not be conducted.There was no sample returned from complainant therefore further investigation could not be conducted to find out the real root cause of the leak as reported.Therefore, complaint could not be further verified.

• Brand Name: PURE GOLD TIEMANN 5-15ML PTFE STR H 16
• Common Device Name: CATHETER, UROLOGICAL
• Manufacturer (Section D): TELEFLEX MEDICAL SDN. BHD.; perak, west malaysia
• MDR Report Key: 12532184
• Report Number: 8040412-2021-00257
• Device Sequence Number: 1350650
• Product Code: KOD
• UDI-Device Identifier: 04026704303106
• UDI-Public: 04026704303106
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/03/2021

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 Model Number: IPN051269
• Device Catalogue Number: 318116
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/03/2021
• Supplement Date Received by Manufacturer: 10/21/2021
• Initial Report FDA Received Date: 09/27/2021
• Supplement Report FDA Received Date: 10/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1