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

Catalog Number	381833
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/22/2025
Type of Reportable Event	Serious Injury
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 the following information was provided by the initial reporter:.
Additional Manufacturer Narrative
Event details added to b tab.Investigation results: our quality engineer inspected the sample submitted for evaluation.Your report of unintended plastic material on the catheter could not be confirmed from the 20g insyte autoguard device that was returned from lot number 4310283.A visual and microscopic examination revealed no damage or defects on the iv catheter.The catheter tip was acceptable according to the visual standard.A device history record review showed no non-conformances associated with this issue during the production of this batch.
Event or Problem Description
Event details: an emergency room nurse alerted me today to the presence of a foreign body, presumably a small piece of hard plastic on the outside of the catheter adapter of a short autoguard 20g 25mm kt ref 381833, lot 4310283, which she saw while pushing the kt into a patient's vein.She immediately removed the kt.This small piece (which she calls a ¿spangle¿ in her statement) fell to the floor as the kt was withdrawn.With other colleagues, she opened a dozen other kts from the same batch and found a similar small piece on a 2nd kt that i recovered and visualized.As no other batch of this size was available in the pharmacy, i was unable to quarantine this batch.

• 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: 22745441
• Report Number: 1710034-2025-01306
• Device Sequence Number: 15580116
• Product Code: FOZ
• UDI-Device Identifier: 00382903818334
• UDI-Public: (01)00382903818334
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: NA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 09/23/2025

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: 381833
• Device Lot Number: 4310283
• 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: 07/22/2025
• Supplement Date Received by Manufacturer: 09/23/2025
• Initial Report FDA Received Date: 08/07/2025
• Supplement Report FDA Received Date: 09/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/06/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown