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

Catalog Number	381544
Medical Device Problem Codes	Retraction Problem (1536); Material Protrusion/Extrusion (2979)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/10/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that the bd insyte¿ autoguard¿ shielded iv catheter was difficult to retract as the spring appeared to be malfunctioning, which in turn caused blood to splatter out and onto the patient and nurse's clothing.There was no exposure to mucosal membrane, and medwatch report# mw 5086636 was opened and filed in response to the event.The following information was provided by the initial reporter: "i placed 18 gauge insyte autoguard iv.When nurse retracted needle, spring appeared to malfunction casing blood spatter to pt and to nurse's clothing.There was no harm, the nurse did not sustain blood exposure to the skin or mucous membranes.No testing completed on the nurse, no interventions provided to the nurse.Fda safety report id# (b)(4)".
Additional Manufacturer Narrative
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.The complaint could not be confirmed and the root cause is undetermined.
Event or Problem Description
It was reported that the bd insyte¿ autoguard¿ shielded iv catheter was difficult to retract as the spring appeared to be malfunctioning, which in turn caused blood to splatter out and onto the patient and nurse's clothing.There was no exposure to mucosal membrane, and medwatch report# mw 5086636 was opened and filed in response to the event.The following information was provided by the initial reporter: "i placed 18 gauge insyte autoguard iv.When nurse retracted needle, spring appeared to malfunction casing blood spatter to pt and to nurse's clothing.There was no harm, the nurse did not sustain blood exposure to the skin or mucous membranes.No testing completed on the nurse, no interventions provided to the nurse.Fda safety report id# (b)(4)".

• Brand Name: BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER
• Common Device Name: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• MDR Report Key: 8708662
• Report Number: 1710034-2019-00640
• Device Sequence Number: 2065501
• Product Code: FOZ
• UDI-Device Identifier: 30382903815440
• UDI-Public: 30382903815440
• Combination Product (Y/N): N
• Initial Reporter State: VT
• Initial Reporter Country: US
• PMA/510(K) Number: K952861
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/26/2019

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: 12/31/2020
• Device Catalogue Number: 381544
• Device Lot Number: 8017557
• Initial Date Received by Manufacturer: 05/20/2019
• Supplement Date Received by Manufacturer: 05/20/2019
• Initial Report FDA Received Date: 06/18/2019
• Supplement Report FDA Received Date: 07/26/2019
• 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