MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY BD NEXIVA; CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS

Model Number	383571
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Laceration(s) (1946)
Date of Event	05/10/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Nurse was inserting iv into pediatric patient and did not get the usual flash verifying vein placement.Once iv cannula removed, nurse note blood in catheter and had been inserted in vein.Also noted vein "blew" after removal.

• Brand Name: BD NEXIVA
• Common Device Name: CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): BECTON, DICKINSON AND COMPANY; 1 becton dr; franklin lakes NJ 07417
• MDR Report Key: 17469572
• Report Number: 17469572
• Device Sequence Number: 20706234
• Product Code: FOZ
• UDI-Device Identifier: 00382903835713
• UDI-Public: (01)00382903835713
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/10/2023
• Report Date (Section F): 05/10/2023

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
• Operator of Device: Health Professional
• Device Model Number: 383571
• Device Catalogue Number: 383571
• Device Lot Number: 3017711
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Device Age: 0 YR
• Event Location: Hospital
• Date Report to Manufacturer: 08/07/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/07/2023
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male
• Patient Weight: 13 KG
• Date Report Sent to FDA: 05/10/2023