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 Problem Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem Insufficient Information (4580)

Event Date 11/27/2020

Event Type  malfunction  

Event Description

Look at the extra piece of plastic/bump towards the tip.Manufacturer response for intima needle 22g, intima (per site reporter).

• 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; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 12597838
• MDR Text Key: 275477008
• Report Number: 12597838
• 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: 09/30/2021

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: 0087323
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/03/2020
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/30/2021
• Device Age: 1 YR
• Event Location: Hospital
• Date Report to Manufacturer: 10/08/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1