MAUDE Adverse Event Report: TELEFLEX MEDICAL SDN. BHD. SILASIL 2-W LATEX/SILICONE FOLEY, CYL.; CATHETER, UROLOGICAL

Model Number IPN050678

Device Problem Patient-Device Incompatibility (2682)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/29/2023

Event Type  malfunction  

Event Description

It was reported that "at the end of the hysterectomy procedure, a thrombosis of the catheter was observed.Another catheter, lot was used, new thrombosis observed.Then another catheter from another lot # was used with success.No patient consequences." see associated mdr #8040412-2023-00308.

Manufacturer Narrative

(b)(4).N/a.Other remarks: n/a.Corrected data: n/a.

Manufacturer Narrative

(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.

Event Description

It was reported that "at the end of the hysterectomy procedure, a thrombosis of the catheter was observed.Another catheter, lot was used, new thrombosis observed.Then another catheter from another lot # was used with success.No patient consequences." associated mdr #8040412-2023-00308.

• Brand Name: SILASIL 2-W LATEX/SILICONE FOLEY, CYL.
• Type of Device: 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: 17436066
• MDR Text Key: 320151599
• Report Number: 8040412-2023-00307
• Device Sequence Number: 1
• Product Code: BYD
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/17/2023

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
• Device Operator: Health Professional
• Device Model Number: IPN050678
• Device Catalogue Number: 186005-000160
• Device Lot Number: KMA23A0860
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/17/2023
• Initial Date FDA Received: 08/01/2023
• Supplement Dates Manufacturer Received: 09/05/2023
• Supplement Dates FDA Received: 09/07/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/22/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1