MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD INSYTE AUTOGUARD; PERIPHERAL IV CATHETERS

Catalog Number 381434

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 02/27/2024

Event Type  malfunction  

Manufacturer Narrative

H.3.A follow up mdr will be submitted if additional information, a device evaluation, or a device history review is completed.E4.The initial reporter also notified the fda on feb 2024.Medwatch report is (b)(4).

Event Description

It was reported that bd insyte autoguard catheter broke.The following information was provided by the initial reporter: describe the event or problem: bd insyte autoguard 20g x 1.16in iv catheter would not advance upon iv insertion.Iv cath and needle removed.Catheter 5mm shorter than before iv insertion attempt.When safety retraction button pushed during withdrawal nurse suspects 5mm of catheter broke loose inside of patient¿s vein.

• Brand Name: BD INSYTE AUTOGUARD
• Type of Device: PERIPHERAL IV CATHETERS
• Manufacturer (Section D): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• Manufacturer (Section G): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 19095371
• MDR Text Key: 340807928
• Report Number: 1710034-2024-00328
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00382903814343
• UDI-Public: (01)00382903814343
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K201075
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 03/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 381434
• Device Lot Number: 3248258
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/20/2024
• Initial Date FDA Received: 04/12/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/07/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Male