MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD INSYTE AUTOG BC PNK 20GA X 1.0IN INTRAVASCULAR CATHETER

Model Number 382533

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/04/2021

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown. The date received by manufacturer has been used for this field. 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 autog bc pnk 20ga x 1. 0in had foreign matter. The following information was provided by the initial reporter: the catheter had some debris on it. Customer was inspecting tip of catheter prior to insertion and noticed some debris on the tip of the catheter. The rn did not inserted the catheter but saved it.

• Brand Name: BD INSYTE AUTOG BC PNK 20GA X 1.0IN
• 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: 12738217
• MDR Text Key: 279626338
• Report Number: 1710034-2021-00934
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K201075
• 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,Followup
• Report Date: 11/29/2021

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 11/02/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 382533
• Device Catalogue Number: 382533
• Device Lot Number: 1144503
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/22/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/29/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/24/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial