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

Catalog Number	392537
Medical Device Problem Code	Retraction Problem (1536)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/07/2021
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.(b)(4).
Event or Problem Description
It was reported that the bd insyte¿ autoguard¿ bc pro shielded iv catheter needle failed to retract as the button was jammed.The following information was provided by the initial reporter: "vat rn successfully placed an iv on a patient on (b)(6) 2021 without any issues.However, when vat rn went to disengage the needle after gaining access to the patient's vein, the needle was unable to retract in the safe housing when the button was pushed.The button was jammed and unable to be pressed.The exposed needle was carefully disposed of safely in the sharps container in the patient's room".
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.The complaint could not be confirmed and the root cause is undetermined.
Event or Problem Description
It was reported that the bd insyte¿ autoguard¿ bc pro shielded iv catheter needle failed to retract as the button was jammed.The following information was provided by the initial reporter: "vat rn successfully placed an iv on a patient on (b)(6) 2021 without any issues.However, when vat rn went to disengage the needle after gaining access to the patient's vein, the needle was unable to retract in the safe housing when the button was pushed.The button was jammed and unable to be pressed.The exposed needle was carefully disposed of safely in the sharps container in the patient's room.".

• Brand Name: BD INSYTE AUTOGUARD BC PRO 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: 11276820
• Report Number: 1710034-2021-00082
• Device Sequence Number: 14464345
• Product Code: FOZ
• UDI-Device Identifier: 00382903925377
• UDI-Public: 00382903925377
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K201075
• 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): 02/12/2021

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: 08/31/2022
• Device Catalogue Number: 392537
• Device Lot Number: 9262427
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/12/2021
• Supplement Date Received by Manufacturer: 02/12/2021
• Initial Report FDA Received Date: 02/03/2021
• Supplement Report FDA Received Date: 02/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1