MAUDE Adverse Event Report: TELEFLEX MEDICAL SDN. BHD. PURE GOLD TIEMANN 30-50ML PTFE STR H 18; CATHETER, UROLOGICAL

Model Number	IPN051285
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/09/2021
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
The catheter balloon burst.
Additional Manufacturer Narrative
(b)(4).The device lot number was not provided; therefore a dhr review could not be conducted.There was no sample returned for this complaint.Therefore evaluation could not be conducted for the reported functionality defect.As simulation, previous complaint reported for similar catalogue number was reviewed, tc20032538.There was no sample returned from complainant therefore further investigation could not be conducted to find out the real root cause of the burst balloon as reported.Therefore, complaint could not be confirmed.
Event or Problem Description
The catheter balloon burst.

• Brand Name: PURE GOLD TIEMANN 30-50ML 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: jasmine brown ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9193614124
• MDR Report Key: 12984082
• Report Number: 8040412-2021-00338
• Device Sequence Number: 17396917
• Product Code: KOD
• UDI-Device Identifier: 04026704303182
• UDI-Public: 04026704303182
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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): 12/13/2021

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: IPN051285
• Device Catalogue Number: 318318
• 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: 12/13/2021
• Supplement Date Received by Manufacturer: 01/27/2022
• Initial Report FDA Received Date: 12/13/2021
• Supplement Report FDA Received Date: 01/28/2022
• 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
• Patient Sex: Unknown