MAUDE Adverse Event Report: BECTON DICKINSON BD INSYTE AUTOGUARD 20Q X 1 INCH; CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS

Catalog Number 3681433

Device Problem Retraction Problem (1536)

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

Event Date 02/16/2023

Event Type  malfunction  

Event Description

Safety needle retracting before needed, very sensitive to any touch.Needle retracts before puncturing skin resulting in having to start over with new iv cath.Safety needle difficult to retract, therefore having to remove needle after starting iv and could pose as a needlestick risk.

• Brand Name: BD INSYTE AUTOGUARD 20Q X 1 INCH
• Type of Device: CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): BECTON DICKINSON
• MDR Report Key: 16437234
• MDR Text Key: 310336849
• Report Number: MW5115153
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 3681433
• Device Lot Number: 2335745
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1