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

Model Number	382634
Medical Device Problem Code	Retraction Problem (1536)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/10/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the bd insyte¿ autoguard¿ bc shielded iv catheter needle did not fully retract after the button was pressed.This complaint was created to capture the 1st of 2 related incidents.The following information was provided by the initial reporter: "rn placed 20g heplock in right anterior chamber.Rn pushes white button to release needle and retraction only occurred partially.".
Additional Manufacturer Narrative
Date of birth: unknown.The patient¿s age was used to determine a placeholder date for this field.Fda notified: the initial reporter also notified the fda via medwatch # (b)(4).A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Additional Manufacturer Narrative
After additional review, this event was determined to be a case of the needle failing to retract rather than the needle being slow to retract.As a result, this event will be marked as a concomitant, cascading failure of the needle through catheter event.Therefore this mdr will be cancelled, and the retraction failure and needle through catheter events will be grouped into the same mdr (mfr# 1710034-2022-00711).
Event or Problem Description
It was reported that the bd insyte¿ autoguard¿ bc shielded iv catheter needle did not fully retract after the button was pressed.This complaint was created to capture the 1st of 2 related incidents.The following information was provided by the initial reporter: "rn placed 20g heplock in right anterior chamber.Rn pushes white button to release needle and retraction only occurred partially.".
Event or Problem Description
It was reported that the bd insyte¿ autoguard¿ bc shielded iv catheter needle did not fully retract after the button was pressed.This complaint was created to capture the 1st of 2 related incidents.The following information was provided by the initial reporter: "rn placed 20g heplock in right anterior chamber.Rn pushes white button to release needle and retraction only occurred partially.".
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.

• Brand Name: BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER
• 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: 15822144
• Report Number: 1710034-2022-00710
• Device Sequence Number: 6157270
• Product Code: FOZ
• UDI-Device Identifier: 00382903826346
• UDI-Public: (01)00382903826346
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• 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,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/08/2022

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: Health Professional
• Device Expiration Date: 04/30/2025
• Device Model Number: 382634
• Device Catalogue Number: 382634
• Device Lot Number: 2146298
• 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: 10/26/2022
• Supplement Date Received by Manufacturer: 10/26/2022; 12/08/2022
• Initial Report FDA Received Date: 11/18/2022
• Supplement Report FDA Received Date: 12/02/2022; 12/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/03/2022
• 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 Age: 76 YR
• Patient Sex: Female
• Patient Weight: 71 KG
• Patient Race: White