MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD INSYTE¿ AUTOGUARD¿ WINGED SHIELDED IV CATHETER 18GA 1.16IN; INTRAVASCULAR CATHETER

Model Number	381544
Medical Device Problem Codes	Leak/Splash (1354); Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	01/02/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
Was reported that thee was an incident with the bd insyte¿ autoguard¿ winged shielded iv catheter 18ga 1.16in during use the wings adapter separated and required medical intervention.Material no.: 381544, batch no.: 9198681.The following information was provided by the initial reporter: verbatim: it was reported that there was an incident with this product and the patient had to have a mri to locate the sheath.It was clarified that the winged adapter separated from the catheter when inserted into patient.
Additional Manufacturer Narrative
H.6.Investigation: 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.Complaint can't be confirmed and the root cause is undetermined.
Event or Problem Description
Was reported that thee was an incident with the bd insyte¿ autoguard¿ winged shielded iv catheter 18ga 1.16in during use the wings adapter separated and required medical intervention.Material no.: 381544 batch no.: 9198681 the following information was provided by the initial reporter: verbatim: it was reported that there was an incident with this product and the patient had to have a mri to locate the sheath.N it was clarified that the winged adapter separated from the catheter when inserted into patient.

• Brand Name: BD INSYTE¿ AUTOGUARD¿ WINGED SHIELDED IV CATHETER 18GA 1.16IN
• Common Device Name: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• MDR Report Key: 9688045
• Report Number: 1710034-2020-00066
• Device Sequence Number: 1810026
• Product Code: FOZ
• UDI-Device Identifier: 30382903815440
• UDI-Public: 30382903815440
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K952861
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2022
• Device Model Number: 381544
• Device Catalogue Number: 381544
• Device Lot Number: 9198681
• Initial Date Received by Manufacturer: 01/19/2020
• Supplement Date Received by Manufacturer: 01/19/2020
• Initial Report FDA Received Date: 02/10/2020
• Supplement Report FDA Received Date: 02/26/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other