MAUDE Adverse Event Report: TELEFLEX MEDICAL SDN. BHD. FLOCATH HYDRO-COATED TIEM; CATHETER, URETHRAL

Model Number	IPN050938
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Pain (1994)
Date of Event	02/24/2022
Type of Reportable Event	Serious 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
Patient stated they used one catheter and they started bleeding.No other details provided.Additional information: patient advised that these are causing pain and bleeding.No injuries or medical intervention were reported.
Additional Manufacturer Narrative
(b)(4).The device lot number was not provided; therefore a dhr review could not be conducted.No physical sample or the lot number provided, the physical testing or dhr review are not able to be performed to further identify any potential root cause from manufacturing processes.Based on the limited information provided, the complaint is not confirmed as the root cause of the defect is not able to be identified.Without the present of the sample for investigation, no physical examination or testing could be conducted to further identify the root cause of the complaint reported.
Event or Problem Description
Patient stated they used one catheter and they started bleeding.No other details provided.Additional information: patient advised that these are causing pain and bleeding.No injuries or medical intervention were reported.

• Brand Name: FLOCATH HYDRO-COATED TIEM
• 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: jasmine brown ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9193614124
• MDR Report Key: 13839089
• Report Number: 8040412-2022-00057
• Device Sequence Number: 870867
• Product Code: GBM
• UDI-Device Identifier: 04026704318339
• UDI-Public: 04026704318339
• 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
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: IPN050938
• Device Catalogue Number: 220850140
• 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: 02/24/2022
• Supplement Date Received by Manufacturer: 04/14/2022
• Initial Report FDA Received Date: 03/21/2022
• Supplement Report FDA Received Date: 04/14/2022
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male