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

Catalog Number	381837
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	01/06/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that bd insyte autoguard catheter remained in the patient.The following information was provided by the initial reporter: customer from hospital had issue while using the iv cannula.The cannula had ¿tissued¿ and was to be removed.Upon removing the ivc it was noted that the ¿straw¿ component of the cannula did not come with the bung attachment and was retained in the patient¿s vein.This required surgical intervention to remove.The cannula had been insitu for approximately 72hours and had become occluded ¿ unable to flush or withdraw blood.Ultrasound confirmed that the ¿straw¿ component had remained in the patient.
Additional 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.
Additional Manufacturer Narrative
Event date updated in b tab.Investigation results: the complaint of a broken bd insyte autoguard iv catheter could not be confirmed as the device in the provided photograph does not resemble a bd insyte autoguard.The physical sample was not returned for investigation.The photo does not support damage to a bd insyte autoguard iv catheter.If additional information or sample is provided for investigation, the complaint will be reevaluated for the reported issue.A review of our risk management documentation was performed and indicates that the potential risk of the reported event was assessed appropriately.
Event or Problem Description
Event date is unknown.

• Brand Name: BD INSYTE AUTOGUARD
• Common Device Name: 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: 21220547
• Report Number: 1710034-2025-00054
• Device Sequence Number: 11642119
• Product Code: FOZ
• UDI-Device Identifier: 00382903818372
• UDI-Public: (01)00382903818372
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: UNK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/25/2025

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
• Operator of Device: Health Professional
• Device Catalogue Number: 381837
• Device Lot Number: UNKNOWN
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/06/2025
• Supplement Date Received by Manufacturer: 02/25/2025
• Initial Report FDA Received Date: 01/23/2025
• Supplement Report FDA Received Date: 02/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown