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

Catalog Number 381044

Device Problem Retraction Problem (1536)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 11/13/2021

Event Type  malfunction  

Event Description

It was reported bd insyte autoguard bc had slow needle retraction and blood backflow issues resulting in blood exposure.The following information was provided by the initial reporter, translated from french: "when the catheter was inserted, the nurse wanted to take a blood sample at the same time.When the safety needle was removed, it did not retract immediately.Moreover, blood came out of the catheter, whereas there is normally a backflow preventer on the device.".

Manufacturer Narrative

Investigation summary: since no samples displaying the condition reported were available for examination, we were unable to fully investigate this incident.Examination of the actual product involved may provide clarification as to the cause for the reported failure.A device history record review showed no non-conformances 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.Customer complaint trends are evaluated on a monthly basis, however the need for a formal corrective action cannot be determined in the absence of the root cause.Our business team regularly reviews the collected data for identification of emerging trends.

• Brand Name: BD INSYTE AUTOGUARD BC
• 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: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 13002350
• MDR Text Key: 284306474
• Report Number: 1710034-2021-01050
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K201075
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 381044
• Device Lot Number: 1137808
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/15/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/17/2021
• 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