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

Catalog Number	382633
Medical Device Problem Codes	Crack (1135); Leak/Splash (1354)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/06/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that bd insyte autog bc wing hub was cracked and leaked blood.The following information was provided by the initial reporter: a nurse placed a piv on a patient, and blood began pouring out of a crack in the hub.The date - (b)(6) 2025.
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.
Additional Manufacturer Narrative
Additional information received.Annex e/f codes updated.
Event or Problem Description
Additional information tue 03/25/2025 10:27 am a nurse placed a piv on a patient, and blood began pouring out of a crack in the hub.No harm to the patient.Iv catheter was removed and catheter tip was intact.
Additional Manufacturer Narrative
Investigation results: our quality engineer inspected the sample submitted for evaluation.Your report of a leak from a damaged hub was confirmed and the cause appeared to be manufacturing related.One 20ga insyte autoguard iv catheter from lot number 4260455 was provided for investigation.A longitudinal crack was observed in the pink catheter adapter over the wedge, which allowed fluid to leak.This damage may occur when the adapter encounters the grippers due to a misalignment.A device history record review showed no non-conformances associated with this issue during the production of this batch.The appropriate personnel have been notified, and we appreciate you taking the time to bring this observation to our attention.
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: 21683909
• Report Number: 1710034-2025-00463
• Device Sequence Number: 21026305
• Product Code: FOZ
• UDI-Device Identifier: 00382903826339
• UDI-Public: (01)00382903826339(11)240916(17)270831(10)4260455
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/21/2025

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: 382633
• Device Lot Number: 4260455
• 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: 03/06/2025
• Supplement Date Received by Manufacturer: Not provided; 04/21/2025
• Initial Report FDA Received Date: 03/24/2025
• Supplement Report FDA Received Date: 03/27/2025; 04/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/16/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown