MAUDE Adverse Event Report: BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER; INTRAVASCULAR CATHETER

Model Number 381444

Device Problems Leak/Splash (1354); Improper Flow or Infusion (2954)

Patient Problem Exposure to Body Fluids (1745)

Event Date 06/24/2021

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.

Event Description

It was reported when using the bd insyte autoguard shielded iv catheter the blood control feature does not work.The following information was provided by the initial reporter.The customer stated: "the iv insertion does not have blood control features therefore blood pours out of the catheter tip after insertion and before the j-loop is hooked up.".

Manufacturer Narrative

H6: investigation summary bd was unable to perform a thorough investigation as no sample, lot, or batch number were provided.A device history review could not be completed as no batch number was provided.It should be noted that the reported material number is a device that does not contain the blood control feature.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly. our business team regularly reviews the collected data for identification of emerging trends.

Event Description

It was reported when using the bd insyte¿ autoguard¿ shielded iv catheter the blood control feature does not work.The following information was provided by the initial reporter.The customer stated: "the iv insertion does not have blood control features therefore blood pours out of the catheter tip after insertion and before the j-loop is hooked up.".

• Brand Name: BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER
• Type of Device: INTRAVASCULAR CATHETER
• MDR Report Key: 12211290
• MDR Text Key: 262955593
• Report Number: 1710034-2021-00602
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 30382903814443
• UDI-Public: 30382903814443
• Combination Product (y/n): N
• PMA/PMN Number: K952861
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 08/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 381444
• Device Catalogue Number: 381444
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/26/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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