MAUDE Adverse Event Report: TELEFLEX MEDICAL SDN. BHD. FLOCATH QUICK COUDE 12FR; CATHETER, URETHRAL

Catalog Number	220600120
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Codes	Exsanguination (1841); Insufficient Information (4580)
Date of Event	08/14/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that "patient said that these are causing bleeding.No medical attention reported".At the time of this report the customer has not returned our requests for additional information.If additional information is received, the complaint file will be updated.
Event or Problem Description
It was reported that "patient said that these are causing bleeding.No medical attention reported".At the time of this report the customer has not returned our requests for additional information.If additional information is received, the complaint file will be updated.
Additional Manufacturer Narrative
(b)(4).Referring to the process of this product, flocath quick coude xrn220600160 undergo surmodics coating process with uv and heat curing, followed by silicone oil wipe to ensure the shaft lubricity for smooth insertion.Curing and adhesion of the coating layer on the catheter shaft is ensured by conducting coating presence test on the product batch with 3 pieces sampling every 2 hours.A device history record review was performed, and no relevant findings were identified.Input of the coating process also monitored (ie.Solution viscosity and uv light intensity) ensured to be within the validated range.The customer complaint could not be confirmed as no representative sample is provided for investigation and due to established process control.Teleflex will continue to monitor and trend for reports of this nature.

• Brand Name: FLOCATH QUICK COUDE 12FR
• Common Device Name: CATHETER, URETHRAL
• 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: mariah mackinnon ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 17642236
• Report Number: 8040412-2023-00336
• Device Sequence Number: 15437988
• Product Code: GBM
• UDI-Device Identifier: 04026704331062
• UDI-Public: 04026704331062
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K183461
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/15/2023

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: Lay User/Patient
• Device Catalogue Number: 220600120
• 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: 08/15/2023
• Supplement Date Received by Manufacturer: 10/03/2023
• Initial Report FDA Received Date: 08/29/2023
• Supplement Report FDA Received Date: 10/10/2023
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown