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

Catalog Number	382644
Medical Device Problem Code	Retraction Problem (1536)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/14/2025
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
It was reported that bd insyte autog bc wing needle slow to retract.The following information was provided by the initial reporter: rn pushed button to retract the needle but needle was stuck inside the hub of the catheter.Rn lifted the catheter and the needle eventually retracted.No prior damage noted to catheter when opening.Describe patient /(hcp) / user impact: none.Other comments: catheter was opened but not used on patient.
Additional Manufacturer Narrative
Our quality engineer inspected the sample submitted for evaluation.Your report that the needle was stuck inside the hub of the catheter could not be confirmed from the 18ga insyte autoguard bc winged unit that was provided for investigation.The needle was received fully retracted within the safety shield and the iv catheter was received separate from the needle.After resetting the safety mechanism, a functional test showed that the needle fully retracted without getting stuck.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.

• Brand Name: BD INSYTE AUTOG BC WING
• 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: 22680258
• Report Number: 1710034-2025-01267
• Device Sequence Number: 21194095
• Product Code: FOZ
• UDI-Device Identifier: 00382903826445
• UDI-Public: (01)00382903826445(10)4123612
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K201075
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/09/2025

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: 382644
• Device Lot Number: 4123612
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/14/2025
• Supplement Date Received by Manufacturer: 09/09/2025
• Initial Report FDA Received Date: 07/31/2025
• Supplement Report FDA Received Date: 09/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown