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

Model Number	381437
Medical Device Problem Code	Retraction Problem (1536)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/21/2022
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 safety mechanism on the bd insyte¿ autoguard¿ shielded iv catheter failed to activate and retract the needle.The following information was provided by the initial reporter: "safety not activating on device".
Additional Manufacturer Narrative
The following fields were updated due to additional information: d.9.Device available for eval?: yes.D.9.Returned to manufacturer on: 25-apr-2022.H.6.Investigation: our quality engineer inspected the sample submitted for evaluation.Bd received one used un-retracted unit with its original packaging from lot number 1300906.Upon inspection of the received unit, it was identified that the button cannot be pressed, and that adhesive is present on the outside of the needle well.The reported issue was confirmed.This was physical/mechanical evidence to confirm and support a manufacturing process related issue for the reported defect relating to the adhesive dispense process due to station or part misalignment or adhesive buildup on the nozzle.Adhesive on the outside of the needle well can flow down between the button and grip preventing the button from moving and causing retraction failure to occur.Operators inspect for adhesive on the outside of the hub and button per the sampling plan.Inspections are also performed during setup and downtime.Maintenance is performed periodically to ensure proper function of the machine.The maintenance records were reviewed and verified to be up to date during the manufacturing of this lot.A device history record review showed no non-conformances associated with this issue during the production of this batch.H3 other text : see h.10.
Event or Problem Description
It was reported that the safety mechanism on the bd insyte¿ autoguard¿ shielded iv catheter failed to activate and retract the needle.The following information was provided by the initial reporter: "safety not activating on device".

• 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
• 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: 14461803
• Report Number: 1710034-2022-00263
• Device Sequence Number: 20008521
• Product Code: FOZ
• UDI-Device Identifier: 30382903814375
• UDI-Public: 30382903814375
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/27/2022

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: 10/31/2024
• Device Model Number: 381437
• Device Catalogue Number: 381437
• Device Lot Number: 1300906
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/21/2022
• Supplement Date Received by Manufacturer: 05/27/2022
• Initial Report FDA Received Date: 05/20/2022
• Supplement Report FDA Received Date: 06/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/03/2021
• 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