MAUDE Adverse Event Report: BD DIAGNOSTIC SYSTEMS / BECTON DICKINSON & CO. CULTURE VIALS; SYSTEM, BLOOD CULTURING

Device Problems Expiration Date Error (2528); Manufacturing, Packaging or Shipping Problem (2975)

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

Event Date 12/30/2021

Event Type  malfunction  

Event Description

On (b)(6) 2021 becton dickinson, (b)(4) shipped two cases of bactec platelet anaerobic/f culture vials with an expiration date of 12/31/2021 to (b)(6).Fda safety report id# (b)(4).

• Brand Name: CULTURE VIALS
• Type of Device: SYSTEM, BLOOD CULTURING
• Manufacturer (Section D): BD DIAGNOSTIC SYSTEMS / BECTON DICKINSON & CO.; sparks MD 21152
• MDR Report Key: 13358483
• MDR Text Key: 284657887
• Report Number: MW5106966
• Device Sequence Number: 2
• Product Code: MDB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/21/2022
• 2 Devices were Involved in the Event: 1 2

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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/25/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1