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

Catalog Number	382612
Medical Device Problem Codes	Retraction Problem (1536); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/08/2025
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 was slow to retract.The following information was provided by the initial reporter:¿ needle did not retract promptly, and catheter would not thread off needle when inserting peripheral iv.There is a significant glitch when pressing the retract button.I had to pull the needle all the way out, exposed, before it would retract.I tested a couple others with the same lot number; they were slow to retract.¿ kindly provide the date of event.5/8/25 any adverse event or serious injury reported to patient or healthcare professional? if yes, please provide the details.None to my knowledge.
Event or Problem Description
No additional information.
Additional Manufacturer Narrative
Correction: cancel mdr.Upon further review by analyst/sme, this event is not mdr reportable because the primary failure, tip adhesion, is not mdr reportable.No injuries.

• 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: 22119565
• Report Number: 1710034-2025-00924
• Device Sequence Number: 14483808
• Product Code: FOZ
• UDI-Device Identifier: 00382903826124
• UDI-Public: (01)00382903826124
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 06/08/2025

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: 382612
• Device Lot Number: 4292347
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/13/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/30/2025
• Supplement Report FDA Received Date: 06/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/18/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown