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	Obstruction of Flow (2423)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/05/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn#(b)(4).The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.
Event or Problem Description
Reported issue: customer states catheter is not draining.
Additional Manufacturer Narrative
Qn#(b)(4).Additional information: there was no patient injury, no kidney stones, incrustation, or urinary infection, and the device has been in use for 15 hours.Investigation: there was no sample returned for further investigation.As our own initiative, simulation test was done using a representative sample.Visual examination on the representative sample did not reveal any obvious defect or abnormality.There was no sign of kinking, clamp mark or collapse airline observed throughout the shaft.The catheters then were inflated with 10ml of water using a 10ml luer tip syringe.The balloons inflated without any difficulties faced.No latex particle or other foreign particle seen within the balloon.The inflation eye was normal and no collapse of the inflation airline observed.Leaving the inflated balloon for 30 minutes showed no sign of leak on any part of the catheter.Deflations of the balloons by connecting empty luer tip syringe barrel to the valve were smooth, spontaneous and complete.Repeat of inflation and deflation using the attached syringe gave similar observation with no problem experienced.There was no sample returned from complainant therefore further investigation could not be conducted to find out the real root cause of the non-drainage as reported.From simulation test, no abnormality found on the representati ve sample.Therefore, complaint could not be confirmed.
Event or Problem Description
Reported issue: customer states catheter is not draining.

• 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
• Manufacturer (Section G): TELEFLEX MEDICAL SDN. BHD.; lot no : pt2577 jalen perusahaan; 4 kamunting industrial estate; perak, west malaysia 34600 ; MY 34600
• Manufacturer Contact: effie jefferson ; 3015 carrington mill blvd; morrisville 27560 ; 9194332672
• MDR Report Key: 16039676
• Report Number: 8040412-2022-00349
• Device Sequence Number: 6219254
• Product Code: KOD
• UDI-Device Identifier: 04026704303106
• UDI-Public: 04026704303106
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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: Consumer,Health Professional,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/07/2022

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 Model Number: IPN051269
• Device Catalogue Number: 318116
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/07/2022
• Supplement Date Received by Manufacturer: 01/26/2023
• Initial Report FDA Received Date: 12/22/2022
• Supplement Report FDA Received Date: 02/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NONE REPORTED; NONE REPORTED
• Patient Sex: Unknown