MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. INSYTE-N AUTOGUARD WINGED ANGIOCATHETER; CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS

Model Number 381511

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 03/01/2021

Event Type  Injury  

Event Description

When piercing the skin, the top of the catheter sheared away from the stylet and slid on top of the skin.The catheter never entered the vein.The stylet was removed from the puncture, was intact and was discarded.No equipment remained in the site.Pressure was held at the failed site and a new identical device was used to start an iv in a different anatomical location.No harm to the patient other than needing stuck a second time.Fda safety report id # (b)(4).

• Brand Name: INSYTE-N AUTOGUARD WINGED ANGIOCATHETER
• Type of Device: CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; sandy UT 84070
• MDR Report Key: 11854799
• MDR Text Key: 251943315
• Report Number: MW5101436
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Public: (01)00.82903815111
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 05/17/2021

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 Expiration Date: 08/31/2023
• Device Model Number: 381511
• Device Lot Number: 0265013
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/19/2021
• 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 Outcome(s): Required Intervention
• Patient Age: 6 DA
• Patient Weight: 1