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

Catalog Number	381834
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/24/2025
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.
Event or Problem Description
"catheta area black foreign object.".
Additional Manufacturer Narrative
Our quality engineer inspected the photograph and sample submitted for evaluation.Your reported issue of unintended material within the packaging was confirmed; however, the source and composition of the material could not be determined.One photograph and one 20g insyte autoguard were provided for investigation.The device was received in opened packaging and the material that was visible within the photograph was not present on the returned device.The material was visible on the needle cover and not in a critical location, such as the fluid path.The material was likely dislodged from manipulation.A device history record review showed no non-conformances associated with this issue during the production of this batch.
Event or Problem Description
No new information.
Additional Manufacturer Narrative
Investigation results clarification: the complaint regarding unintended material within the packaging was confirmed; however, the source and composition of the material could not be determined because it was inadvertently dislodged during the investigation and became unrecoverable.One photograph and a 20g insyte autoguard device were provided for evaluation.The device was received in opened packaging, and a black speck was observed on the iv catheter tubing.During handling and manipulation of the device, the material was inadvertently dislodged and could not be recovered for analysis.The needle was received fully retracted within the safety shield, which indicates that the device was manipulated after opening.As the device had been opened, it could not be determined with certainty whether the material was introduced during manufacturing or manipulation of the device in the clinical setting.There were no other similar complaints from the implicated lot.Complaints for this device and reported condition will continue to be tracked and trended as part of ongoing efforts to identify potential manufacturing-related issues.This information will be captured in trend reports and monitored regularly.The bd business team reviews collected data to identify any emerging trends and take appropriate action as needed.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 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: 23299919
• Report Number: 1710034-2025-01623
• Device Sequence Number: 11977946
• Product Code: FOZ
• UDI-Device Identifier: 00382903818341
• UDI-Public: (01)00382903818341(11)241015(17)270831(10)4289409
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K201075
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/12/2026

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: 381834
• Device Lot Number: 4289409
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/25/2025
• Supplement Date Received by Manufacturer: 12/02/2025; 01/12/2026
• Initial Report FDA Received Date: 10/15/2025
• Supplement Report FDA Received Date: 12/03/2025; 01/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/15/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown