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

Catalog Number	382944
Medical Device Problem Code	Retraction Problem (1536)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/03/2022
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¿ bc winged shielded iv catheter blood control technology needle caught onto the catheter during the retraction process.The following information was provided by the initial reporter: "an 18g insyte autogaurd bc pro wined iv catheter did not work correctly.After piercing the skin and vein with flash seen, the cath over needle was advanced a bit more ensuring it was placed properly in the vein.The catheter was started to be advanced over the needle to set it into the vein.The button was pressed so the needle could retract, and when it retracted it caught onto the catheter and pulled it out of the pt's skin, causing bleeding and a large hematoma.Impact of incident: pressure was applied and all information about the incident was disclosed to the pt.The bleeding quickly stopped with pressure and gauze.Who was affected? patient".
Additional Manufacturer Narrative
H6: investigation summary 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 that the bd insyte¿ autoguard¿ bc winged shielded iv catheter blood control technology needle caught onto the catheter during the retraction process.The following information was provided by the initial reporter: "an 18g insyte autogaurd bc pro wined iv catheter did not work correctly.After piercing the skin and vein with flash seen, the cath over needle was advanced a bit more ensuring it was placed properly in the vein.The catheter was started to be advanced over the needle to set it into the vein.The button was pressed so the needle could retract, and when it retracted it caught onto the catheter and pulled it out of the pt's skin, causing bleeding and a large hematoma.Impact of incident: pressure was applied and all information about the incident was disclosed to the pt.The bleeding quickly stopped with pressure and gauze.Who was affected? patient.".

• Brand Name: BD INSYTE¿ AUTOGUARD¿ BC WINGED SHIELDED IV CATHETER BLOOD CONTROL TECHNOLOGY
• 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: 15899588
• Report Number: 1710034-2022-00735
• Device Sequence Number: 5078642
• Product Code: FOZ
• UDI-Device Identifier: 00382903829446
• UDI-Public: (01)00382903829446
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/20/2022

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: Other
• Device Expiration Date: 03/31/2025
• Device Catalogue Number: 382944
• Device Lot Number: 2087312
• 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: 11/07/2022
• Supplement Date Received by Manufacturer: 12/20/2022
• Initial Report FDA Received Date: 12/01/2022
• Supplement Report FDA Received Date: 01/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/31/2022
• 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