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

Catalog Number	INCORRECT ENTRY
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	Pain (1994)
Date of Event	02/14/2025
Type of Reportable Event	Malfunction
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.
Event or Problem Description
It was reported that bd insyte autoguard catheter tip was broken.The following information was provided by the initial reporter, translated from spanish to english: 1.When cannulating the patient, the distal tip was broken, which prevented the passage of the needle, and at the time of removal, the patient reported a lot of pain.
Event or Problem Description
Clarification received that the reported failure on the initial mdr did not occur with this lot number.
Additional Manufacturer Narrative
Correction: cancel mdr.Clarification received that the reported failure on the initial mdr did not occur with this lot number.

• 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: 21601821
• Report Number: 1710034-2025-00397
• Device Sequence Number: 9261957
• Product Code: FOZ
• UDI-Device Identifier: 00382903818440
• UDI-Public: (01)00382903818440(11)230227(17)260228(10)3055708
• Combination Product (Y/N): N
• Initial Reporter Country: PE
• PMA/510(K) Number: K201075
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/31/2025

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
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2026
• Device Catalogue Number: INCORRECT ENTRY
• Device Lot Number: INCORRECT ENTRY
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/14/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/13/2025
• Supplement Report FDA Received Date: 03/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/27/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown