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

Model Number 383323

Device Problems Retraction Problem (1536); Fail-Safe Did Not Operate (4046)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/13/2023

Event Type  malfunction  

Event Description

Saf-t-intima iv needle retraction safety device failed when rn placed iv into patient.The needle did not retract/safety device did not cover the needle.Long flimsy needle was waving around after being disengaged from the catheter.

• Brand Name: BD SAF-T-INTIMA
• Type of Device: CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): BECTON, DICKINSON AND COMPANY; one becton drive; franklin lakes NJ 07417
• MDR Report Key: 16426671
• MDR Text Key: 310054137
• Report Number: 16426671
• 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: Nurse
• Type of Report: Initial
• Report Date: 02/14/2023

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
• Device Operator: Health Professional
• Device Model Number: 383323
• Device Catalogue Number: 383323
• Device Lot Number: 2105307
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/14/2023
• Event Location: Hospital
• Date Report to Manufacturer: 02/23/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/23/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 23360 DA
• Patient Sex: Female