MAUDE Adverse Event Report: BECTON DICKINSON INSYTE AUTOGUARD WINGED BL 22GA X 1.0IN; CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS

Catalog Number	381523
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/08/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial mdr submission.A follow up mdr will be submitted if additional information, a device evaluation, or a device history review is completed.
Event or Problem Description
Material#: 381523 batch#: 4093016.It was reported by the customer that after the iv was placed, the extension was connected to flush but leaked where the extension and iv hub met.I tried changing the extension but it still was leaking at the connection the iv needed to be removed due to the failure.2.Was there any harm to the patient or healthcare provider (hcp)? no 3.What was the date of the event? 10-8-24 5.What medication was being administered at the time of the incident? saline.
Additional Manufacturer Narrative
Initial reporter address updated in e tab.Investigation results: our quality engineer inspected the sample submitted for evaluation.Bd received one unsealed 22ga x 1.00in.Insyte autoguard bc unit from lot number 4093016.Only the catheter was provided, and no media was detected.A leak test was performed and confirmed a leak from the connection of the adapter.Microscopic analysis discovered damage to the bottom of the adapter where the luer threads form.Your reported issue was confirmed and determined to be manufacturing related.During manufacturing, this may occur when the adapter is loaded onto the grip assembly due to incorrect equipment settings.A device history record review showed no non-conformances associated with this issue during the production of this batch.
Event or Problem Description
No additional information.

• Brand Name: INSYTE AUTOGUARD WINGED BL 22GA X 1.0IN
• Common Device Name: CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• 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: 20924911
• Report Number: 1710034-2024-01485
• Device Sequence Number: 17407252
• Product Code: FOZ
• UDI-Device Identifier: 00382903815234
• UDI-Public: (01)00382903815234(10)4093016
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 02/04/2025

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: 4093016
• 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: 12/02/2024
• Supplement Date Received by Manufacturer: 02/04/2025
• Initial Report FDA Received Date: 12/13/2024
• Supplement Report FDA Received Date: 02/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown