MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD INSYTE¿ AUTOGUARD¿ WINGED SHIELDED IV CATHETER 22GA 1.00IN; INTRAVASCULAR CATHETER

Catalog Number	381923
Medical Device Problem Code	Air/Gas in Device (4062)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/25/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported while using bd insyte¿ autoguard¿ winged shielded iv catheter 22ga 1.00in there was a connection issue resulting in air in the line.There was no report of patient impact.The following information was provided by the initial reporter, translated from japanese to english: this report is about connection failure.When blood was collected with a syringe, air came in.
Additional Manufacturer Narrative
H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
This report is about connection failure.When blood was collected with a syringe, air came in.
Additional Manufacturer Narrative
Investigation results: our quality engineer inspected the sample and photographs submitted for evaluation.Bd received one used 22g x 1.00in.Insyte autoguard winged unit from lot number 2290794.Additionally, five photos were provided for investigation.The photos are representative of what was returned and do not provide any additional evidence that isn¿t already covered by the physical sample evaluation.A gross visual inspection of the returned unit did not identify any damage to the components.The unit was tested for leakage where a leak was identified originating from the luer hub.Further inspection under a microscope found that a portion of the inside wall of the catheter adapter near the luer hub was sheared.The unit was functionally tested for aspiration and air was noted to be pulled in during aspiration.The reported issue was confirmed and determined to be manufacturing related as the adapter/connector of the device was found damaged.Damage to the luer may occur due to misalignment between the adapter and manufacturing equipment resulting in excess force to the wall of the adapter.Operators perform sampling per the quality plan to detect and mitigate the occurrence of this defect.Additionally, preventative maintenance (pm) is performed to ensure proper functioning of the manufacturing equipment.A device history record review showed no non-conformances associated with this issue during the production of this batch.The appropriate personnel have been notified.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.

• Brand Name: BD INSYTE¿ AUTOGUARD¿ WINGED SHIELDED IV CATHETER 22GA 1.00IN
• 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: jennifer suh ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17752981
• Report Number: 1710034-2023-01059
• Device Sequence Number: 12565245
• Product Code: FOZ
• UDI-Device Identifier: 00382903819232
• UDI-Public: (01)00382903819232
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: NA
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/30/2023

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: 09/30/2025
• Device Catalogue Number: 381923
• Device Lot Number: 2290794
• 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: 08/29/2023
• Supplement Date Received by Manufacturer: 10/30/2023
• Initial Report FDA Received Date: 09/15/2023
• Supplement Report FDA Received Date: 11/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/26/2022
• 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