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

Catalog Number	381044
Medical Device Problem Codes	Nonstandard Device (1420); Retraction Problem (1536); Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/14/2025
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
Description of the event: it was reported that during the insertion of a peripheral venous catheter, the equipment malfunctioned.The needle safety device did not work.When the nurse activated the needle withdrawal device, it remained stuck in the catheter, preventing the anti-reflux system from functioning.Furthermore, when the nurse tried to pull on the catheter body to remove the needle, the spring prevented her from pulling the needle out safely.The catheter was a bd insyte autogard bc pro 18gax1.16in (1.3x30mm) with lot number 5030831.The same thing happened to another nurse during the same shift with the same catheter.Consequence of the event: risk of aes and risk of injury to the patient.
Additional Manufacturer Narrative
The complaint that the needle did not fully retract was confirmed and the cause appeared to be manufacturing related.Representative 18g insyte autoguard bc devices from lot #5030831 were provided for investigation.A functional test showed that the catheter was able to loosen from the needle and no tip adhesion or spring damage appeared to contribute to the reported issue.Each safety mechanism was activated, which allowed each needle to retract; however, for some needles, the flash notch became caught on the blood control valve.After manipulating the iv catheter, the needle ended up fully retracting within the safety shield.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 new information.

• Brand Name: INSYTE AUTOG BC GLOBAL
• 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: 23372777
• Report Number: 1710034-2025-01646
• Device Sequence Number: 15940206
• Product Code: FOZ
• UDI-Device Identifier: 00382903810444
• UDI-Public: (01)00382903810444
• 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: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/05/2025

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: 381044
• Device Lot Number: 5030831
• 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: 10/03/2025
• Supplement Date Received by Manufacturer: 12/04/2025
• Initial Report FDA Received Date: 10/23/2025
• Supplement Report FDA Received Date: 12/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/31/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown