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

Catalog Number 382544

Device Problem Material Puncture/Hole (1504)

Patient Problem Insufficient Information (4580)

Event Date 03/20/2024

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.B3.The date received by manufacturer has been used for this field.

Event Description

It was reported that bd insyte autoguard bc needle pierced the catheter.The following information was provided by the initial reporter: we received a report of an insyte autoguard bc that malfunctioned while trying to thread off the catheter when starting an iv.When the product was removed the catheter was bent with the needle piercing it.

• Brand Name: BD INSYTE AUTOGUARD BC
• 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: 19085048
• MDR Text Key: 340684845
• Report Number: 1710034-2024-00314
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00382903825448
• UDI-Public: (01)00382903825448
• 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: User Facility
• Reporter Occupation: Non-Healthcare Professional
• 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?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 382544
• Device Lot Number: 3335678
• Initial Date Manufacturer Received: 03/20/2024
• Initial Date FDA Received: 04/10/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/06/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: A
• Patient Sequence Number: 1