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

Catalog Number	381523
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/19/2024
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.
Event or Problem Description
It was reported that bd insyte autoguard winged hub is cracked.The following information was provided by the initial reporter: this writer placed piv to patient right hand with bd 22g insyte iv lot # 4270233.Piv insertion was placed with no difficulty and once needle was retracted from catheter that was placed bleeding was noted to be coming from what appeared to be at puncture site (under blue wings of iv).Iv catheter required to be removed from patient and it was noted that there was a crack on under side of blue wings.This required another piv attempt and poke for a scared patient which was unnecessary due to this defective device.(b)(6) 2025.1.What is the date of event? - 12/19/24.2.Describe any patient harm, injury, complication or negative outcome that occurred as a result of the event.- this required another piv attempt and poke for a scared patient which was unnecessary due to this defective device.
Additional Manufacturer Narrative
Investigation results: the complaint of a crack in the blue catheter adapter was confirmed and the cause was likely manufacturing related.One video was provided for investigation, which showed a longitudinal crack in the blue catheter adapter of the 22g insyte autoguard winged iv catheter.Liquid leaked from the crack.Although the sample exhibited evidence of use, the damage was likely associated with the manufacturing process.The appropriate manufacturing personnel were notified of this complaint.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
No additional information.

• Brand Name: BD INSYTE AUTOGUARD WINGED
• 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: 21175308
• Report Number: 1710034-2025-00022
• Device Sequence Number: 19908662
• Product Code: FOZ
• UDI-Device Identifier: 00382903815234
• UDI-Public: (01)00382903815234(11)241001(17)270831(10)4270233
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K201075
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/20/2025

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 Catalogue Number: 381523
• Device Lot Number: 4270233
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/30/2024
• Supplement Date Received by Manufacturer: 03/20/2025
• Initial Report FDA Received Date: 01/16/2025
• Supplement Report FDA Received Date: 03/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/01/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown