MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. MULTI-LUMEN CENTRAL VENOUS CATHETERIZATION KIT; CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS

Lot Number 23F19L0140

Device Problems Failure to Advance (2524); Deformation Due to Compressive Stress (2889)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  Injury  

Event Description

We have had numerous instances when the guidewires in the central line kits "kink" and will not advance.This has caused delay in treatment and additional cost to the facility because he have to open 2 (sometimes) 3 kits to get one that will advance.

• Brand Name: MULTI-LUMEN CENTRAL VENOUS CATHETERIZATION KIT
• Type of Device: CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): ARROW INTERNATIONAL INC.
• MDR Report Key: 10658238
• MDR Text Key: 211060551
• Report Number: MW5097174
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 10/07/2020
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 05/31/2021
• Device Lot Number: 23F19L0140
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/08/2020
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization