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

Catalog Number	382634
Medical Device Problem Code	Retraction Problem (1536)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/18/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that bd - insyte autog bc wing needle did not retract.The following information was provided by the initial reporter: needle would not retract.
Additional Manufacturer Narrative
D.Lot # 4399165 was provided.It is not found related to the reported material number 382634.H.3.A follow up mdr will be submitted if additional information, a device evaluation, or a device history review is completed.B3.The date received by manufacturer has been used for this field.
Additional Manufacturer Narrative
Investigation results: as no physical sample, picture sample, or lot number was provided for evaluation by our quality engineer team, a complete investigation could not be performed.Based on the limited investigation results, a root cause for the reported incident could not be determined.
Event or Problem Description
No additional 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: 21526256
• Report Number: 1710034-2025-00360
• Device Sequence Number: 9565187
• Product Code: FOZ
• UDI-Device Identifier: 00382903826346
• UDI-Public: (01)00382903826346(10)4399165
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K201075
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 03/25/2025

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: Other
• Device Catalogue Number: 382634
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/18/2025
• Supplement Date Received by Manufacturer: 03/25/2025
• Initial Report FDA Received Date: 03/05/2025
• Supplement Report FDA Received Date: 03/26/2025
• 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