MAUDE Adverse Event Report: TELEFLEX MEDICAL SDN. BHD. RUSCH GOLD FOLEY CATHTER, 3 WAY; CATHETER, UROLOGICAL

Model Number	IPN050616
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/28/2021
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
This is 2nd catheter used for same patient.Catheter was placed after initial catheter slid out of patient in recovery from bladder tumor removal surgery.When nurse tried to remove this catheter after 24 hours she found that it had not retained the sterile water in the retention balloon.Catheter was still in place and functioning properly but balloon had failed.
Additional Manufacturer Narrative
Qn#(b)(4).The device lot number was not provided; therefore, a dhr review could not be conducted.There was no complaint device returned for investigation.The catheter came out during use , could possibly be due to hole or leak on the catheter balloon.Hole or leak balloon could be occurred due to various reasons.However, in the absence of returned sample and limited information available for this complaint, further investigation could not be conducted and therefore complaint is not confirmed.
Event or Problem Description
This is 2nd catheter used for same patient.Catheter was placed after initial catheter slid out of patient in recovery from bladder tumor removal surgery.When nurse tried to remove this catheter after 24 hours she found that it had not retained the sterile water in the retention balloon.Catheter was still in place and functioning properly but balloon had failed.

• Brand Name: RUSCH GOLD FOLEY CATHTER, 3 WAY
• 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: 12712216
• Report Number: 8040412-2021-00273
• Device Sequence Number: 4550722
• Product Code: KOD
• UDI-Device Identifier: 14026704303943
• UDI-Public: 14026704303943
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/13/2021

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: IPN050616
• Device Catalogue Number: 183430220
• Device Lot Number: UNKNOWN
• 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: 10/13/2021
• Supplement Date Received by Manufacturer: 11/26/2021
• Initial Report FDA Received Date: 10/28/2021
• Supplement Report FDA Received Date: 11/30/2021
• 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: N/A.
• Patient Sex: Male