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

Model Number 382523

Device Problem Material Frayed (1262)

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

Event Date 09/21/2021

Event Type  malfunction  

Manufacturer Narrative

Investigation summary: bd received no sample and one photo.Inspection of the photo revealed the catheter adapter assembly was intact over the needle with the tip of the needle piercing through the catheter tubing wall.The defect of needle through catheter was confirmed.There was no media visible; however, it was noted in the event description that the unit had been used in venipuncture.No other anomalies or damage could be observed to the unit or components due to the limited view in the photo.Since the unit had been used, it is unlikely that the defect occurred during manufacturing as the device would have been received with the needle piercing through the catheter tubing, making a venipuncture attempt unlikely.A needle spear through may occur in the user setting during tip adhesion break, during venipuncture if the needle is advanced at a wrong angle, or if the needle is moved up and down the catheter tubing.A device history record review showed no non-conformance's associated with this issue during the production of this batch.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.Our business team regularly reviews the collected data for identification of emerging trends.

Event Description

It was reported bd insyte¿ autoguard¿ bc shielded iv catheter blood control technology had a sheared catheter.The following information was provided by the initial reporter: "iv was inserted into patient, rn did not see any blood return, rn attempted to maneuver iv to get blood return, but expressed that the iv felt "weird" in the patient, so she removed the entire device.Upon removing device, she noticed that the catheter was sheared".

• Brand Name: BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER BLOOD CONTROL TECHNOLOGY
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• MDR Report Key: 12682203
• MDR Text Key: 278360056
• Report Number: 1710034-2021-00909
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 30382903825234
• UDI-Public: 30382903825234
• Combination Product (y/n): N
• PMA/PMN Number: K110443
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial
• Report Date: 10/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 382523
• Device Catalogue Number: 382523
• Device Lot Number: 1182812
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/24/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1