MAUDE Adverse Event Report: BD BD IV INSYTE 20G; CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS

Lot Number 2265973

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Bruise/Contusion (1754); Swelling/ Edema (4577)

Event Date 01/28/2023

Event Type  malfunction  

Event Description

Immediately after insertion of iv catheter, insertion site appeared to be bruised and swollen.Staff was still able to draw blood and flush the catheter without any issues.This occurred at two different locations and departments - with each one reporting multiple occurrences.All devices had the same lot # which was pulled, and the manufacturer was notified.Reference report: mw5115091.

• Brand Name: BD IV INSYTE 20G
• Type of Device: CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): BD
• MDR Report Key: 16417354
• MDR Text Key: 310094949
• Report Number: MW5115092
• 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: 02/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 2265973
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/10/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 71 YR
• Patient Sex: Female
• Patient Weight: 87 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White