MAUDE Adverse Event Report: THROMBOLEX BASHIR ENDOVASCULAR CATHETER PLUS 40; INFUSION CATHETER

Model Number 7240

Device Problem Fluid/Blood Leak (1250)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 02/10/2021

Event Type  malfunction  

Event Description

Bleeding occurred from the wire lumen port (proximal luer) after it broke off, 5 hours or so into infusion in the icu.Patient had a ct scan (time of scan not specified).No infusion of blood was required.The guidewire port is only used to place the catheter in the desired location; then the wire is removed.The lumen of the guidewire is 0.018 (18 thousandths) of an inch in diameter i.E.Very small and venous back pressure into this lumen would be < 10 mm hg.Corrective action resulted in a design change to the proximal luer to make it more flexible to prevent breakage for the entire product line of catheters.

• Brand Name: BASHIR ENDOVASCULAR CATHETER PLUS 40
• Type of Device: INFUSION CATHETER
• Manufacturer (Section D): THROMBOLEX; 75 britain drive; new britain PA 18901
• Manufacturer (Section G): THROMBOLEX; 75 britain drive; new britain PA 18901
• Manufacturer Contact: amy katsikis ; 75 britain drive; new britain, PA 18901 ; 2678983986
• MDR Report Key: 16772986
• MDR Text Key: 313752926
• Report Number: 3015489145-2023-00001
• Device Sequence Number: 1
• Product Code: QEY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 7240
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/11/2021
• Date Manufacturer Received: 02/15/2021
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 40 YR
• Patient Sex: Male