MAUDE Adverse Event Report: BARD / BECTON DICKINSON STERILE PORT ACCESS ADULT KIT; SET, ADMINISTRATION, INTRAVASCULAR

Model Number "7829D"

Device Problem Contamination /Decontamination Problem (2895)

Patient Problem Insufficient Information (4580)

Event Date 01/05/2022

Event Description

A dead bug was found inside sterile glove package inside a sterile port access adult kit.Ref# 3006260740-2021-00396.

• Brand Name: STERILE PORT ACCESS ADULT KIT
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BARD / BECTON DICKINSON
• MDR Report Key: 13976428
• MDR Text Key: 288495681
• Report Number: MW5108676
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 01/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Expiration Date: 03/15/2023
• Device Model Number: "7829D"
• Device Lot Number: 291169
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Patient Ethnicity: Non Hispanic
• Patient Race: White