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

Catalog Number	381944
Medical Device Problem Code	Retraction Problem (1536)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/31/2025
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
It was reported that bd insyte autoguard winged needle partially retracted.The following information was provided by the initial reporter: date of incident (b)(6) 2025 level of harm: no apparent harm - reached the patient/person -- inconvenient incident details: writer inserted 18g iv in patient for ct contrast.Successful iv insertion.Writer pressed the button to retract the needle and placed in on the bed beside patient's right leg.When writer went to grab the tegaderm dressing, she saw that the needle retracted, but the end of the needle was poking out of the tip of the plastic tube.Writer collected same and put it in a container and showed charge nurse and then the supplier of the ed.No one was injured during this event.Although, it was a near miss if writer did not see the needle before she grabbed all the garbage.
Event or Problem Description
No additional information.
Additional Manufacturer Narrative
Investigation results: our quality engineer inspected the sample submitted for evaluation.Your report that the needle did not fully retract was confirmed from the circumstantial evidence that was observed on the returned sample and the cause appeared to be manufacturing related.The sample exhibited evidence of use.A microscopic examination of the sample revealed that the spring was damaged.When the needle was fully extended from the shield, one end of the spring extended from the grip, which indicates that the spring was bound and the damage likely prevented the needle from fully retracting during use.A device history record review showed no non-conformances associated with this issue during the production of this batch.

• Brand Name: BD INSYTE AUTOGUARD WINGED
• 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: 21860912
• Report Number: 1710034-2025-00627
• Device Sequence Number: 17326410
• Product Code: FOZ
• UDI-Device Identifier: 00382903819447
• UDI-Public: (01)00382903819447(11)241116(17)271031(10)4317775
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: UNK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/29/2025

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: 381944
• Device Lot Number: 4317775
• 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: 04/02/2025
• Supplement Date Received by Manufacturer: 05/29/2025
• Initial Report FDA Received Date: 04/17/2025
• Supplement Report FDA Received Date: 05/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/16/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown