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

Model Number	IPN050863
Medical Device Problem Code	Delivered as Unsterile Product (1421)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/03/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn# (b)(4).
Event or Problem Description
The patient reported that packaging was open at the bottom.At the time of this report, the customer has answered our inquiries but states that there is no other information available.The complaint file will be updated if further information is received.See associated mdrs 8040412-2023-00134, 8040412-2023-00161, 8040412-2023-00160, 8040412-2023-00159, 8040412-2023-00158, 8040412-2023-00176, 8040412-2023-00175, 8040412-2023-00174, 8040412-2023-00173, 8040412-2023-00172, 8040412-2023-00171, 8040412-2023-00170, 8040412-202 3-00169, 8040412-2023-00168, 8040412-2023-00167, 8040412-2023-00166, 8040412-2023-00165, 8040412-2023-00164, 8040412-2023-00163.
Additional Manufacturer Narrative
Qn#(b)(4).Complaint verification testing could not be performed as it was reported that the sample is not available for return.A device history record review was performed and no relevant findings were identified.Without the device to evaluate the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.Other remarks: n/a.Corrected data: n/a.
Event or Problem Description
The patient reported that packaging was open at the bottom.At the time of this report, the customer has answered our inquiries but states that there is no other information available.The complaint file will be updated if further information is received.See associated mdrs 8040412-2023-00134, 8040412-2023-00161, 8040412-2023-00160, 8040412-2023-00159, 8040412-2023-00158, 8040412-2023-00176, 8040412-2023-00175, 8040412-2023-00174, 8040412-2023-00173, 8040412-2023-00172, 8040412-2023-00171, 8040412-2023-00170, 8040412-202 3-00169, 8040412-2023-00168, 8040412-2023-00167, 8040412-2023-00166, 8040412-2023-00165, 8040412-2023-00164, 8040412-2023-00163.

• Brand Name: FLOCATH QUICK HYDROPHILIC
• 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: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 16778134
• Report Number: 8040412-2023-00162
• Device Sequence Number: 20510545
• Product Code: GBM
• UDI-Device Identifier: 04026704323883
• UDI-Public: 04026704323883
• 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,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/04/2023

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 Model Number: IPN050863
• Device Catalogue Number: 220400140
• Device Lot Number: KME22D0529
• 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: 04/04/2023
• Supplement Date Received by Manufacturer: 05/24/2023
• Initial Report FDA Received Date: 04/20/2023
• Supplement Report FDA Received Date: 05/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/28/2022
• 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