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

Model Number 382644

Device Problem Leak/Splash (1354)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 05/25/2020

Event Type  malfunction  

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 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.Our business team regularly reviews the collected data for identification of emerging trends.

Event Description

It was reported bd insyte¿ autoguard¿ bc winged shielded iv catheter blood control technology 18ga 1.16in catheter dislodged upon needle retraction.The following information was provided by the initial reporter: ".Stated that one was placed without difficulty, once the needle was retracted the catheter was dislodged from the vein due to pressure prior to being able to tape it down.Blood splatter was noted.Multiple attempts to place.".

• Brand Name: BD INSYTE AUTOGUARD BC WINGED SHIELDED IV CATHETER BLOOD CONTROL
• 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: 12256685
• MDR Text Key: 264846482
• Report Number: 1710034-2021-00651
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 30382903826446
• UDI-Public: 30382903826446
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K110443
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/26/2021

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: Health Professional
• Device Expiration Date: 12/31/2022
• Device Model Number: 382644
• Device Catalogue Number: 382644
• Device Lot Number: 0028051
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/01/2021
• Initial Date FDA Received: 07/30/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/28/2020
• 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