MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS, INC. BD INTROSYTE-N AUTOGUARD; INTRODUCER, CATHETER

Catalog Number 306453

Device Problems Break (1069); Difficult to Remove (1528)

Patient Problem Insufficient Information (4580)

Event Date 07/29/2021

Event Type  malfunction  

Event Description

Rn was attempting to insert a picc line.After the third attempt, she was successful.When blood return noted and inserted the catheter, she broke the wings of the introducer to remove the sheath.The wings broke off and left the sheath on the catheter.She attempted to remove the sheath using hemostats which was unsuccessful, so she had to remove the line.Fda safety report id # (b)(4).

• Brand Name: BD INTROSYTE-N AUTOGUARD
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): BECTON DICKINSON INFUSION THERAPY SYSTEMS, INC.
• MDR Report Key: 12266888
• MDR Text Key: 265053722
• Report Number: MW5102946
• Device Sequence Number: 1
• Product Code: DYB
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/02/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2021
• Device Catalogue Number: 306453
• Device Lot Number: 8297893
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1