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

Catalog Number 381923

Device Problems Leak/Splash (1354); Free or Unrestricted Flow (2945)

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

Event Date 06/04/2021

Event Type  malfunction  

Manufacturer Narrative

A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that bd insyte¿ autoguard¿ shielded iv catheter experienced a case of air bubbles in line, and leakage.The following information was provided by the initial reporter: faulty injections due to a sealing problem between the intrabody catheter part of the patient and the external part.Presence of air "bubbles" during the venous return.Passage of the product between these two zones.Description distributor: leakage problem between the intrabody and extrabody catheter parts, presence of air bubbles during venous return, passage of the product between these 2 zones.

Manufacturer Narrative

H.6.Investigation: our quality engineer inspected the photo submitted for evaluation.Bd received one hand drawn photograph highlighting the location of the leak.Unfortunately, without the ability to evaluate and test the affected product, the reported issue could not be confirmed.This is the only known occurrence of this issue being reported for this manufacturing lot, and a device history record review showed no non-conformances associated with this issue during the production of this batch.

Event Description

It was reported that bd insyte¿ autoguard¿ shielded iv catheter experienced a case of air bubbles in line, and leakage.The following information was provided by the initial reporter: faulty injections due to a sealing problem between the intrabody catheter part of the patient and the external part.Presence of air "bubbles" during the venous return.Passage of the product between these two zones.Description distributor: leakage problem between the intrabody and extrabody catheter parts presence of air bubbles during venous return, passage of the product between these 2 zones.

• Brand Name: BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER
• Type of Device: INTRAVASCULAR CATHETER
• MDR Report Key: 12132559
• MDR Text Key: 261770099
• Report Number: 1710034-2021-00553
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• PMA/PMN Number: K201075
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 07/13/2021

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
• Device Operator: Other
• Device Expiration Date: 09/30/2023
• Device Catalogue Number: 381923
• Device Lot Number: 0279633
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/08/2021
• Initial Date FDA Received: 07/07/2021
• Supplement Dates Manufacturer Received: 07/13/2021
• Supplement Dates FDA Received: 08/03/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/05/2020
• 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