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

Model Number	IPN050861
Medical Device Problem Code	Sharp Edges (4013)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	03/16/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).This report represents the unused catheters.The device has not been returned for investigation.
Event or Problem Description
Patient called in and stated that he was severely injured by the catheter he received from us.He was hospitalized due to the catheter having a sharp point at the end, it punctured him and caused bleeding.He stated he found 2 catheters in the shipment he just received with the point on the end.Lot kme21b0115.
Event or Problem Description
Patient called in and stated that he was severely injured by the catheter he received from us.He was hospitalized due to the catheter having a sharp point at the end, it punctured him and caused bleeding.He stated he found 2 catheters in the shipment he just received with the point on the end.Lot kme21b0115.
Additional Manufacturer Narrative
Qn#(b)(4).The batch card(s) for the complaint lot(s) was reviewed and all passed qa inspection.No physical investigation or assessment has been conducted on the defective catheter since no complaint or representative sample returned for investigation.The investigation was conducted based on dhr review.However, no abnormalities was detected.No samples were provided to conduct further investigation.From the simulation using similar product and dhr review, the potential root cause of the complaint defect was unable to be identified.Hence, the complaint is not confirmed.

• Brand Name: FLOCATH QUICK HYDROPHILIC 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: jasmine brown ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9193614124
• MDR Report Key: 13952349
• Report Number: 8040412-2022-00070
• Device Sequence Number: 15098346
• Product Code: GBM
• UDI-Device Identifier: 04026704323876
• UDI-Public: 04026704323876
• Combination Product (Y/N): N
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/16/2022

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 Expiration Date: 01/28/2026
• Device Model Number: IPN050861
• Device Catalogue Number: 220400120
• Device Lot Number: KME21B0115
• 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: 03/16/2022
• Supplement Date Received by Manufacturer: 04/29/2022
• Initial Report FDA Received Date: 03/30/2022
• Supplement Report FDA Received Date: 05/09/2022
• 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: Male