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

Model Number	381534
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/13/2023
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.Date of event: unknown.The date received by manufacturer has been used for this field.
Event or Problem Description
It was reported that 18 bd insyte¿ autoguard¿ iv catheter experienced molding issue that make it difficult to screw.The following information was provided by the initial reporter: reported issue: the customer is stating that the molding is making it difficult to screw in the luer lock.They are bending when you place them.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 17-may-2023.H6: investigation summary our quality engineer inspected the representative samples submitted for evaluation.Bd received 10 20gx1.16in insyte autoguard devices from lot number 3017213.A visual and functional test revealed no damage or defects on the returned samples.First a luer syringe was connected to each unit and it connected without issue.Further, the luer lock syringe was filled water then connected with a luer lock catheter adapter where the catheter was flushed.Leakage was not observed.The needles were inspected, the notch was present on each unit and no damage was observed.No orientation is required between the bevel and the notch for this device.The returned units provided for evaluation met and performed per the required manufacturing specifications.There was no physical/mechanical evidence to confirm and support a manufacturing process related issue for the failures stated in the report.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 18 bd insyte¿ autoguard¿ iv catheter experienced molding issue that make it difficult to screw.The following information was provided by the initial reporter: reported issue: the customer is stating that the molding is making it difficult to screw in the luer lock.They are bending when you place them.

• Brand Name: BD INSYTE¿ AUTOGUARD¿ 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 ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17073241
• Report Number: 1710034-2023-00623
• Device Sequence Number: 6673224
• Product Code: FOZ
• UDI-Device Identifier: 00382903815340
• UDI-Public: (01)00382903815340
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/13/2023

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: 12/31/2025
• Device Model Number: 381534
• Device Catalogue Number: 381534
• Device Lot Number: 3017213
• 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: 05/13/2023
• Supplement Date Received by Manufacturer: 07/13/2023
• Initial Report FDA Received Date: 06/06/2023
• Supplement Report FDA Received Date: 08/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/25/2023
• 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