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	392634
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/27/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H.3.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 tip of the bd insyte¿ autoguard¿ bc winged shielded iv catheter blood control technology was found sheared/frayed when removing it from the packaging.The following information was provided by the initial reporter: "catheter tip was sheared / frayed when the device was taken out of the package".
Additional Manufacturer Narrative
H6: investigation summary: our quality engineer inspected the photograph submitted for evaluation.Bd received one photograph which displayed a 20gx1.16in insyte autoguard blood control from lot number 3129529.The needle was protruding through the catheter near the tip.The observable features on the submitted photographs did not contain enough information to identify a specific root cause of the reported event.Your reported issue was confirmed as the needle pierced the catheter wall.The photo provided for this incident did not present sufficient evidence to establish a definite root cause.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 tip of the bd insyte¿ autoguard¿ bc winged shielded iv catheter blood control technology was found sheared/frayed when removing it from the packaging.The following information was provided by the initial reporter: "catheter tip was sheared / frayed when the device was taken out of the package.".

• 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: jennifer suh ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17502178
• Report Number: 1710034-2023-00907
• Device Sequence Number: 2394606
• Product Code: FOZ
• UDI-Device Identifier: 00382903926343
• UDI-Public: 00382903926343
• 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,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/15/2023

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: 01/31/2026
• Device Catalogue Number: 392634
• Device Lot Number: 3129529
• 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: 07/27/2023
• Supplement Date Received by Manufacturer: 09/15/2023
• Initial Report FDA Received Date: 08/10/2023
• Supplement Report FDA Received Date: 10/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/15/2023
• 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