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

Catalog Number	381844
Medical Device Problem Code	Retraction Problem (1536)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/24/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Our quality engineer inspected the sample submitted for evaluation.Your report that the needle was not retracted could not be confirmed from the shielded needle that was provided for investigation.The needle was received fully retracted within the safety shield.The iv catheter was not returned with the needle.The returned sample exhibited evidence of use.Due to the condition of the returned sample, the complaint could not be confirmed.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.
Event or Problem Description
It was reported that bd insyte autoguard needle reaction issue.The following information was provided by the initial reporter: call from an emergency nurse for a problem with a catheter canula not retracted into the system.He nearly pricked himself with the system.(b)(6) 2025.Has the patient or user been harmed? the patient was not harmed, however the user (a nurse) almost pricked himself with the needle as it did not fully retract.Could you specify the date of the event? the event took place on (b)(6) 2025, the report was made the same day to the pharmacy.
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.

• 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: 22790042
• Report Number: 1710034-2025-01332
• Device Sequence Number: 15518053
• Product Code: FOZ
• UDI-Device Identifier: 00382903818440
• UDI-Public: (01)00382903818440(11)241226(17)271130(10)4361599
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K201075
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/29/2025

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: 381844
• Device Lot Number: 4361599
• 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: 07/28/2025
• Supplement Date Received by Manufacturer: 09/29/2025
• Initial Report FDA Received Date: 08/12/2025
• Supplement Report FDA Received Date: 09/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/26/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown