MAUDE Adverse Event Report: BECTON, DICKINSON INFUSION THERAPY SYSTEMS INC. BD INSYTE-N AUTOGUARD WINGEDBD INSYTE-N AUTOGUARD WINGED YEL 24GAX.56IN; CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS

Model Number 381511

Device Problems Connection Problem (2900); Material Twisted/Bent (2981)

Patient Problem Insufficient Information (4580)

Event Date 02/16/2021

Event Type  malfunction  

Event Description

Nurse was unable to attach extension set at yellow hub.Nurse thought the hub was cracked.After further investigation it is found that the threading hub was bent but did not inhibit the connection of an extension set at the hub.Device was still functional upon closer review.

• Brand Name: BD INSYTE-N AUTOGUARD WINGEDBD INSYTE-N AUTOGUARD WINGED YEL 24GAX.56IN
• Type of Device: CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): BECTON, DICKINSON INFUSION THERAPY SYSTEMS INC.; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 11462087
• MDR Text Key: 239169357
• Report Number: 11462087
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 03/03/2021,02/23/2021

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: No Information
• Device Model Number: 381511
• Device Catalogue Number: 381511
• Device Lot Number: 0265013
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/03/2021
• Date Report to Manufacturer: 03/11/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/11/2021
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other