MAUDE Adverse Event Report: BECTON DICKSON INFUSION THERAPY SYSTEMS INC. BD NEXIVA; CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS

Model Number CE 2797

Device Problems Positioning Failure (1158); Material Puncture/Hole (1504); Physical Resistance/Sticking (4012)

Patient Problems Hematoma (1884); Needle Stick/Puncture (2462)

Event Date 05/26/2023

Event Type  malfunction  

Event Description

During insertion of iv, pre op rn states she received flashback, went on to advance the catheter, she felt resistance, she pulled the catheter back, noticed that the vein appeared "puffy" assumed that the vein had blown, therefore, she removed the catheter and found the needle went through the side of the catheter.

• Brand Name: BD NEXIVA
• Type of Device: CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): BECTON DICKSON INFUSION THERAPY SYSTEMS INC.
• MDR Report Key: 17039741
• MDR Text Key: 316443584
• Report Number: MW5118020
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• 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: 05/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CE 2797
• Device Catalogue Number: 383536
• Device Lot Number: 3019335
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 79 YR
• Patient Sex: Male
• Patient Weight: 73 KG
• Patient Race: White