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

Catalog Number	382612
Medical Device Problem Code	Retraction Problem (1536)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/18/2025
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 did not retract.The following information was provided by the initial reporter: insyte autogaurd needle not retracting.Customer response on 23-apr-2025.Any adverse event or serious injury reported to patient or healthcare professional? if yes, please provide the details.Thankfully there were no adverse events.We had 4 reports of the needles not retracting when pressing the button.Thankfully the staff was able to safely navigate and dispose of the needles without adverse events to patients or staff.
Event or Problem Description
No additional information was provided.
Additional Manufacturer Narrative
The complaint of retraction issues with the insyte autoguard needle was confirmed and the cause appeared to be manufacturing related.Unused representative 24g insyte autoguard units were provided for investigation.A functional test revealed that the retraction time of some units exceeded the specification.The appropriate manufacturing personnel were notified of this complaint.A trend was identified for the reported failure and corrective actions have been implemented to investigate this type of incident and identify the root cause.A review of our risk management documentation was performed and indicates that the potential risk of the reported event was assessed appropriately.

• 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: 21980681
• Report Number: 1710034-2025-00781
• Device Sequence Number: 15700814
• Product Code: FOZ
• UDI-Device Identifier: 00382903826124
• UDI-Public: (01)00382903826124(11)241018(17)270930(10)4292347
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 07/31/2025

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: 04/30/2025
• Supplement Date Received by Manufacturer: 07/31/2025
• Initial Report FDA Received Date: 05/07/2025
• Supplement Report FDA Received Date: 08/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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