MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY BD INSYTE AUTOGUARD; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

Model Number	381454
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/06/2018
Type of Reportable Event	Malfunction
Event or Problem Description
Rn started 16 gauge iv in patient, pressed lock to retract needle, and the needle did not completely retract into the safety housing, leaving approximately 1 inch of the needle including the sharp end exposed.The needle was disposed of in the sharps container, but photograph of needle and packaging was captured.No harm came to the patient or rn.

• Brand Name: BD INSYTE AUTOGUARD
• Common Device Name: CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): BECTON, DICKINSON AND COMPANY; 9450 s state street; sandy UT 84070
• MDR Report Key: 7468060
• Report Number: 7468060
• Device Sequence Number: 16442973
• Product Code: FOZ
• UDI-Device Identifier: 00382903814541
• UDI-Public: (01)00382903814541
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/25/2018
• Report Date (Section F): 04/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Nurse
• Device Expiration Date: 06/30/2020
• Device Model Number: 381454
• Device Catalogue Number: 381454
• Device Lot Number: 7201989
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Device Age: 0 YR
• Event Location: Hospital
• Date Report to Manufacturer: 04/25/2018
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/27/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 04/25/2018