MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD INSYTE AUTOGUARD BC PRO WINGED, 20G X 1.00"; INTRAVASCULAR CATHETER

Model Number	392633
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/29/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported while using bd insyte autoguard bc pro winged, 20g x 1.00 there was an issue of leakage.The following information was provided by the initial reporter: "the anesthesiologist was putting an iv in my wife's arm, i heard her say this thing made a mess, and it wasn't supposed to do that.Blood got all over and the dr.Said she expected the valve to close.This happened in the pre-op room, and there was nothing out of the ordinary from what i could tell.".
Additional Manufacturer Narrative
A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation and/or device history review, a supplemental report will be filed.
Additional Manufacturer Narrative
H6: investigation summary: the photo provided for this incident did not present sufficient evidence to identify or confirm the alleged failure or to establish a definite root cause.The photo displayed the top web label only.Since no samples displaying the condition reported were available for examination, we were unable to fully investigate this incident.A device history record review showed no non-conformances associated with this issue during the production of this batch.
Event or Problem Description
It was reported while using bd insyte autoguard bc pro winged, 20g x 1.00 there was an issue of leakage.The following information was provided by the initial reporter: "the anesthesiologist was putting an iv in my wife's arm, i heard her say this thing made a mess, and it wasn't supposed to do that.Blood got all over and the dr.Said she expected the valve to close.This happened in the pre-op room, and there was nothing out of the ordinary from what i could tell.".

• Brand Name: BD INSYTE AUTOGUARD BC PRO WINGED, 20G X 1.00"
• Common Device Name: INTRAVASCULAR CATHETER
• 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15135601
• Report Number: 1710034-2022-00404
• Device Sequence Number: 14754451
• Product Code: FOZ
• UDI-Device Identifier: 00382903926336
• UDI-Public: 00382903926336
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K201075
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/15/2022

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 Expiration Date: 02/28/2025
• Device Model Number: 392633
• Device Catalogue Number: 392633
• Device Lot Number: 2082792
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/29/2022
• Supplement Date Received by Manufacturer: 08/15/2022
• Initial Report FDA Received Date: 07/29/2022
• Supplement Report FDA Received Date: 09/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/23/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown