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

Catalog Number	381923
Medical Device Problem Code	Retraction Problem (1536)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/16/2025
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 was slow to retract.The following information was provided by the initial reporter: insyte autoguard inside the iv insertion kit issued in ahmc has been reported having a defect while they push the button for needle encapsulation of the catheter.They have mentioned that they have a hard time using it as it delays needle encapsulation which makes the button harder to press during insertion.(b)(6) 2025 it was detected after use once the button was pressed for encapsulation.No patient was impacted, but the nurses from different departments already raised same concern from the account.
Additional Manufacturer Narrative
Our quality engineer inspected the photograph submitted for evaluation.Your report of slow needle retraction could not be confirmed from the photograph that was provided for investigation.The photo only showed the unit packaging.The device and the reported issue were not shown or demonstrated in the image.A device history record review showed no non-conformances associated with this issue during the production of this batch.However, a trend was identified for the reported failure and corrective actions have been implemented to investigate this type of incident and identity the root cause.
Event or Problem Description
No additional information.

• 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: 22395480
• Report Number: 1710034-2025-01131
• Device Sequence Number: 13016028
• Product Code: FOZ
• UDI-Device Identifier: 00382903819232
• UDI-Public: (01)00382903819232
• Combination Product (Y/N): N
• Initial Reporter Country: RP
• PMA/510(K) Number: NA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 08/26/2025

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: 381923
• Device Lot Number: 4222720
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/18/2025
• Supplement Date Received by Manufacturer: 08/26/2025
• Initial Report FDA Received Date: 07/03/2025
• Supplement Report FDA Received Date: 08/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/15/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown