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

Catalog Number 382512

Device Problem Material Twisted/Bent (2981)

Patient Problem Hematoma (1884)

Event Date 09/02/2022

Event Type  malfunction  

Event Description

It was reported while using bd insyte¿ autoguard¿ bc shielded iv catheter blood control technology the needle pierced the catheter.The following information was provided by the initial reporter: "24 gauge piv catheter was inserted into the patient.The needle pierced through the plastic piv catheter causing it to bend inside the patients vein causing a hematoma.

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 while using bd insyte¿ autoguard¿ bc shielded iv catheter blood control technology the needle pierced the catheter.The following information was provided by the initial reporter: "24 gauge piv catheter was inserted into the patient.The needle pierced through the plastic piv catheter causing it to bend inside the patients vein causing a hematoma.

Manufacturer Narrative

H6: 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.Our business team regularly reviews the collected data for identification of emerging trends.

• Brand Name: BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER BLOOD CONTROL TECHNOLOGY
• 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15506236
• MDR Text Key: 301160990
• Report Number: 1710034-2022-00566
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00382903825127
• UDI-Public: 00382903825127
• 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,Followup
• Report Date: 11/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 382512
• Device Lot Number: 2087316
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/30/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/31/2022
• 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