MAUDE Adverse Event Report: BECTON DICKINSON THERAPY SYSTEM INC. BD INSYTE AUTOGUARD BC IV CATHETER; CATHETER, INTRAVASCULAR THERAPEUTIC SHORT-TERM, LESS THAN 30 DAYS

Catalog Number 382544

Device Problems Defective Component (2292); Failure to Advance (2524)

Patient Problem Needle Stick/Puncture (2462)

Event Date 02/14/2020

Event Type  malfunction  

Event Description

Bd catheter tip defective and unable to advance through the skin on insertion.Only needle tip would penetrate skin, resistance met and removed catheter.Upon examination of iv catheter, noticed tip was defective.Iv was in no way manipulated prior to insertion.This caused pt an unnecessary stick to the left lateral forearm.Fda safety report id# (b)(4).

• Brand Name: BD INSYTE AUTOGUARD BC IV CATHETER
• Type of Device: CATHETER, INTRAVASCULAR THERAPEUTIC SHORT-TERM, LESS THAN 30 DAYS
• Manufacturer (Section D): BECTON DICKINSON THERAPY SYSTEM INC. ; sandy UT 84070
• MDR Report Key: 9744864
• MDR Text Key: 180857878
• Report Number: MW5093219
• Device Sequence Number: 1
• Product Code: FOZ
• 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: 02/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/03/2022
• Device Catalogue Number: 382544
• Device Lot Number: 9331186
• 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
• Patient Age: 68 YR
• Patient Weight: 70