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

Model Number	IPN051271
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/16/2023
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
Reported issue: some of the catheters will not deflate.Some leak so we are not obtaining the same cc that is put into the balloon.The channel proximal to the y was leaking, so when inflating the balloon the sterile water was spraying out.
Additional Manufacturer Narrative
(b)(4).There was no sample returned for further investigation.As our own initiative, simulation test was done using representative sample from complaint sample.Visual examination on the complaint sample did not reveal any obvious defect or abnormality.There was no sign of leak, 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 leak as reported.From simulation test, no abnormality found on the representative sample.Therefore, complaint could not be confirmed.
Event or Problem Description
Reported issue: some of the catheters will not deflate.Some leak so we are not obtaining the same cc that is put into the balloon.The channel proximal to the y was leaking, so when inflating the balloon the sterile water was spraying out.

• 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: bryanna connelly ; 3015 carrington mill blvd; morrisville 27560 ; 9194332672
• MDR Report Key: 16529998
• Report Number: 8040412-2023-00102
• Device Sequence Number: 16870114
• Product Code: KOD
• UDI-Device Identifier: 04026704303113
• UDI-Public: 04026704303113
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 02/17/2023

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: IPN051271
• Device Catalogue Number: 318118
• Device Lot Number: UNKNOWN
• 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: 02/17/2023
• Supplement Date Received by Manufacturer: 04/07/2023
• Initial Report FDA Received Date: 03/13/2023
• Supplement Report FDA Received Date: 04/10/2023
• 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