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

Catalog Number	381523
Medical Device Problem Codes	Crack (1135); Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/31/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that bd insyte autoguard winged hub cracked and leaked.The following information was provided by the initial reporter: product complaint - while using the wingtip iv catheter, a crack was discovered at the bottom of the wing tip which leaked out blood from the pt.No pt harm or blood exposure to hcp.
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
No additional information.
Additional Manufacturer Narrative
Investigation results: our quality engineer inspected the sample submitted for evaluation.Bd received one unsealed 22ga x 1.00in.Insyte autoguard winged unit from lot number 4276445.Only the catheter was provided, attached to an extension device.Media was present, indicating use.A visual inspection discovered there was a crack across the adapter leading up to the nose of the adapter.Your reported issue was confirmed and determined to be manufacturing related.During manufacturing, this may occur when the parts are transferred from rotate grippers to conveyor, misalignment of hardware (rotate grippers, etc.) may cause adapter damage.The appropriate personnel have been notified and we appreciate you taking the time to bring this observation to our attention.A device history record review showed no non-conformances associated with this issue during the production of these batches.

• 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: 21404634
• Report Number: 1710034-2025-00252
• Device Sequence Number: 8317146
• Product Code: FOZ
• UDI-Device Identifier: 00382903815234
• UDI-Public: (01)00382903815234(11)241004(17)270930(10)4276445
• Combination Product (Y/N): Y
• Initial Reporter State: PA
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/27/2025

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: 381523
• Device Lot Number: 4276445
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/31/2025
• Supplement Date Received by Manufacturer: 03/27/2025
• Initial Report FDA Received Date: 02/18/2025
• Supplement Report FDA Received Date: 03/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/04/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown