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

Catalog Number 382523

Device Problem Material Twisted/Bent (2981)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/01/2023

Event Type  malfunction  

Event Description

It was reported that the bd insyte¿ autoguard¿ bc shielded iv catheter tip was jagged.The following information was provided by the initial reporter: "tip of catheter was jagged therefore unable to thread.Defect not noticed prior to iv start.Patient screamed in pain with initial stick, rn unable to thread therefore iv catheter was taken out.".

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.Investigation summary - a physical sample was not available for investigation but bd was provided with a photo of the issue for evaluation.A review of the device history record was performed for the reported lot, 2286182, and no quality issues were found during production.Our quality engineer reviewed the provided photo and observed a packaging label for a 22 gauge insyte autoguard, a 24 gauge insyte autoguard device, and a 24 gauge insyte autoguard needle/catheter hub assembly.However, the engineer could not identify a 22 gauge insyte autoguard device in the provided photo and without a photo of the actual device could not perform a thorough inspection into the reported issue regarding the 22 gauge device.With the information available in the provided photo the engineer could not identify any issues with the 22 gauge insyte autoguard's catheter tip.Therefore, based off the provided photo the engineer could not verify the reported defect.Since no defects could be identified for the 22 gauge device in the provided photo a definitive root cause could not be determined.The manufacturing facility has been notified of this incident and the findings.Complaints received for this product and condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.Our business regularly reviews the collected data for identification of emerging trends.

• Brand Name: BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER
• Type of Device: 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 ; 8448235433
• MDR Report Key: 16457707
• MDR Text Key: 310416994
• Report Number: 1710034-2023-00154
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00382903825233
• UDI-Public: 00382903825233
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K110443
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 382523
• Device Lot Number: 2286182
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/01/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/18/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1