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

Catalog Number 381467

Device Problems Leak/Splash (1354); Device Contamination with Chemical or Other Material (2944)

Patient Problem No Code Available (3191)

Event Date 09/19/2019

Event Type  Injury  

Manufacturer Narrative

Medical device expiration date: unknown. A device evaluation and/or device history review is anticipated, but is not complete. Upon completion, a supplemental report will be filed. Device manufacture date: unknown.

Event Description

It was reported that bd insyte¿ autoguard¿ shielded iv catheter separated from the hub during use. The following information was provided by the initial reporter: material no. : 381467 batch no. : unknown. It was reported that the catheter separated from the hub of the iv and remained in the patient's arm. Good morning, there was an event reported on rhoads 4 that needs f/u. We do not have the catheter. I have copied clinical leadership on this email in order to expedite the information gathering process. Please keep in mind we do not share patient information. Patient had a left ac 14g iv. Iv no longer indicated. Upon removing iv, catheter separated from hub of iv and remained in patient's vein. Transplant md came to bedside and was able to retrieve catheter. Patient required small incision to remove catheter that was then covered with a steristrip.

• Brand Name: BD INSYTE¿ AUTOGUARD¿ 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: 9227042
• MDR Text Key: 176891846
• Report Number: 1710034-2019-01135
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K952861
• 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: 11/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 381467
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No Answer Provided
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 10/02/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 10/23/2019 Patient Sequence Number: 1