MAUDE Adverse Event Report: ARROW INTERNATIONAL, LLC (SUBSIDIARY OF TELEFLEX INCORPORATED) ARROW CENTRAL VENOUS CATHETERIZATION KIT; CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS

Model Number IPN036437

Patient Problems Exposure to Body Fluids (1745); Laceration(s) (1946)

Event Date 06/25/2023

Event Type  malfunction  

Event Description

Clinician was stuck with guidewire upon removal due to guidewire uncoiling from itself, leaving the sharp end exposed.

• Brand Name: ARROW CENTRAL VENOUS CATHETERIZATION KIT
• Type of Device: CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): ARROW INTERNATIONAL, LLC (SUBSIDIARY OF TELEFLEX INCORPORATED)
• MDR Report Key: 17651783
• MDR Text Key: 322508625
• Report Number: MW5145060
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 08/24/2023

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: IPN036437
• Device Lot Number: 33F23B0359
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/29/2023
• Patient Sequence Number: 1
• Patient Outcome(s): Other