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

Catalog Number 381023

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Thrombosis (2100)

Event Date 01/01/2020

Event Type  malfunction  

Manufacturer Narrative

Investigation: since no samples displaying the condition reported were available for examination, we were unable to fully investigate this incident.A device history record review showed no non-conformances associated with this issue during the production of this batch.The complaint could not be confirmed and the root cause is undetermined.

Event Description

It was reported that bd insyte¿ autoguard¿ bc shielded iv catheter was used and venous thrombosis occurred.This was discovered during use.The following information was provided by the initial reporter: diabetic ketoacidosis, catheter put in at 2:00 p.M.With immediate infusion.Clinical consequences observed: superficial venous thrombosis of the vein, despite optimal conditions of use.Precautionary measures taken: we now refuse to use the catheters due to recurrent problems of venous thrombosis issues.The catheters have been withdrawn from service.

Manufacturer Narrative

A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It was reported that bd insyte¿ autoguard¿ bc shielded iv catheter was used and venous thrombosis occurred.This was discovered during use.The following information was provided by the initial reporter: diabetic ketoacidosis, catheter put in at 2:00 p.M.With immediate infusion.Clinical consequences observed: superficial venous thrombosis of the vein, despite optimal conditions of use.Precautionary measures taken: we now refuse to use the catheters due to recurrent problems of venous thrombosis issues.The catheters have been withdrawn from service.

• 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: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652341
• MDR Report Key: 9667270
• MDR Text Key: 182251129
• Report Number: 1710034-2020-00051
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K110443
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 04/30/2022
• Device Catalogue Number: 381023
• Device Lot Number: 9127879
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/15/2020
• Initial Date FDA Received: 02/04/2020
• Supplement Dates Manufacturer Received: 01/15/2020
• Supplement Dates FDA Received: 02/28/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/07/2019
• 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
• Patient Outcome(s): Other