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

Catalog Number	381412
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/23/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
In this mdr, bd franklin lakes, nj has been listed in sections d.3.And g.1.As the manufacturing site is unknown.
Event or Problem Description
It was reported that the catheter shredded.I inserted the catheter and needle and immediately the skin started to bleed at the insertion site.I pulled out the catheter, retracted the needle, and noticed the catheter had shredded.Was there injury? yes.Additional information received 3/6/26: any adverse event or serious injury reported to patient or healthcare professional? if yes, please provide the details: no adverse events or serious injury to caregiver or patient.
Additional Manufacturer Narrative
The complaint of a damaged catheter was confirmed; however, the root cause could not be determined.One 24g insyte autoguard iv catheter was provided for investigation.The needle was not provided for investigation.The catheter tubing exhibited needle puncture damage near the tip.What appeared to be blood residue was visible within the catheter tubing, which indicates the damage may have occurred during use, but the root cause could not be determined.Manufacturing controls are in place to mitigate the occurrence of this type of failure.The ifu indicates to not reinsert the needle into the catheter during the insertion process as damage may occur.The complaint has been documented and will continue to be monitored as part of ongoing efforts to identify potential manufacturing related issues.A review of our risk management documentation was performed and indicates that the potential risk of the reported event was assessed appropriately.Complaints received about this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.Our business team regularly reviews the data collected for identification of emerging trends.
Event or Problem Description
No new information.

• Brand Name: 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: 24546296
• Report Number: 1710034-2026-00238
• Device Sequence Number: 14884357
• Product Code: FOZ
• UDI-Device Identifier: 00382903814121
• UDI-Public: (01)00382903814121(11)251119(17)280930(10)5283690
• Combination Product (Y/N): N
• Initial Reporter State: UT
• 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,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/31/2026

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: 381412
• Device Lot Number: 5283690
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/24/2026
• Supplement Date Received by Manufacturer: 03/31/2026
• Initial Report FDA Received Date: 03/09/2026
• Supplement Report FDA Received Date: 03/31/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/19/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown