MAUDE Adverse Event Report: BD BD NEXIVA DIFFUSICS CLOSED IV CATHETER SYSTEM; CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS

Lot Number 1209927

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 02/03/2022

Event Type  malfunction  

Event Description

At insertion of a bd nexiva diffusics 22 gauge 1 inch catheter into the left cephalic ac vein bleeding was noted at the puncture site.The iv hub was removed as bleeding at the insertion site is abnormal.Upon removal of the hub there was no catheter sheath attached to the hub.X-ray was preformed and a 2.9 cm linear radiopaque foreign body of the lateral aspect of the antecubital fossa was seen and consistent with a retained iv cannula.Patient was transported to the emergency department and the foreign body was removed at the bedside.Fda safety report id #(b)(4).

• Brand Name: BD NEXIVA DIFFUSICS CLOSED IV CATHETER SYSTEM
• Type of Device: CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): BD
• MDR Report Key: 13499699
• MDR Text Key: 285454982
• Report Number: MW5107306
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00038290385911
• UDI-Public: (01)00038290385911
• 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: 02/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 1209927
• 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 Outcome(s): Other
• Patient Age: 29 YR
• Patient Sex: Female
• Patient Weight: 115 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: American Indian Or Alaskan Native