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	02/20/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Reported issue: the catheters stopped draining.The device was removed and replaced.There was no injury.
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
Reported issue: the catheters stopped draining.The device was removed and replaced.There was no injury.
Additional Manufacturer Narrative
(b)(4).Complaint verification testing could not be performed as no sample has yet been received at the manufacturing facility for evaluation.In the absence of a sample, the batch card(s) for the complaint lot(s) was reviewed.No relevant findings were identified.A simulation test was done using representative sample from complaint sample under mdr 8040412-2019-00250.Visual examination on the representative sample from mdr 8040412-2019-00250 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.In summary, as the complaint sample has not been received at our facility, 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 representative sample from complaint mdr 8040412-2019-00250.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: 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: marling heaton ; 3015 carrington mill blvd; morrisville 27560 ; 9194332672
• MDR Report Key: 16467581
• Report Number: 8040412-2023-00095
• Device Sequence Number: 20129216
• Product Code: KOD
• UDI-Device Identifier: 04026704303106
• UDI-Public: 04026704303106
• Combination Product (Y/N): N
• Initial Reporter State: NH
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/20/2023

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 Model Number: IPN051269
• Device Catalogue Number: 318116
• Device Lot Number: KMA22C0203
• 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: 02/20/2023
• Supplement Date Received by Manufacturer: 04/11/2023
• Initial Report FDA Received Date: 03/02/2023
• Supplement Report FDA Received Date: 04/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/28/2022
• 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: A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NONE REPORTED; NONE REPORTED
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown