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

Model Number 383516

Device Problem Malposition of Device (2616)

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

Event Date 06/29/2019

Event Type  malfunction  

Event Description

Employee opened iv catheter and needle was exposed through plastic cannula manufacturer response for iv catheter system, db nexiva (per site reporter).Equipment failure reported to manufacturer bd complaints coordinator.Bd complaint # (b)(4).Product returned to manufacturer.

• Brand Name: BD NEXIVA
• Type of Device: CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): BECTON, DICKINSON AND COMPANY; 9450 south state street; sandy UT 84070
• MDR Report Key: 8944582
• MDR Text Key: 155963583
• Report Number: 8944582
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/25/2019,07/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 383516
• Device Catalogue Number: 383516
• Device Lot Number: 9087932
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/25/2019
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/25/2019
• Event Location: Hospital
• Date Report to Manufacturer: 08/29/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1