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

Catalog Number	381533
Medical Device Problem Code	Retraction Problem (1536)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/04/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
None reported.
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: i was onsite with the staff yesterday and observed one of the issues.On the instye autoguard, the needle is retracting slowly back into the housing when safetied.We pulled one from the stock room and tested it, not on a patient of course.
Additional Manufacturer Narrative
Investigation results: the complaint of slow needle retraction could not be confirmed from the two photographs that were provided for investigation.The photos show the top web containing the device information.No physical sample was provided for functional testing.A review of manufacturing records was performed and there were no issues during the production of this batch.Although the photographs and manufacturing records do not support the complainant¿s description of the reported event, the complaint has been documented and will continue to be monitored as part of ongoing efforts to identify potential manufacturing related issues.A review of our risk management documentation was performed and indicates that the potential risk of the reported event was assessed appropriately.
Event or Problem Description
No additional information.
Additional Manufacturer Narrative
Additional information of fa#.

• 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: 21462444
• Report Number: 1710034-2025-00313
• Device Sequence Number: 12809281
• Product Code: FOZ
• UDI-Device Identifier: 00382903815333
• UDI-Public: (01)00382903815333(11)241016(17)270930(10)4282452
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/16/2025

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: 381533
• Device Lot Number: 4282452
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/12/2025
• Supplement Date Received by Manufacturer: 04/23/2025; 06/13/2025
• Initial Report FDA Received Date: 02/25/2025
• Supplement Report FDA Received Date: 04/23/2025; 06/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/16/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: MDS-25-5274
• Patient Sequence Number: 1
• Patient Sex: Unknown