MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY BD BACTEC; SYSTEM, BLOOD CULTURING

Model Number 442021

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

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

Event Date 09/09/2022

Event Type  malfunction  

Event Description

This event report reflects a situation impacting multiple patients.While no "harm" reached patients, many received unnecessary antibiotics and additional blood cultures.The solution will require an sop/policy impacting mmb (materials management), microbiology.Other affected departments include preanalytical lab services (phlebotomy), ed, and multiple nursing units.Microbiology leadership has noted an uptick in blood cultures with growth of an uncommon organism, paenibacillus urinalis.Specimens were obtained in multiple locations throughout the hospital.Collectors include nurses and phlebotomists.We strongly suspect a problem at the level of the manufacturer.Mmb obtains blood culture bottles from the vendor and distributes them to the floor.

• Brand Name: BD BACTEC
• Type of Device: SYSTEM, BLOOD CULTURING
• Manufacturer (Section D): BECTON, DICKINSON AND COMPANY; 7 loveton circle; sparks MD 21152
• MDR Report Key: 16239953
• MDR Text Key: 308082295
• Report Number: 16239953
• Device Sequence Number: 1
• Product Code: MDB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 442021
• Device Catalogue Number: 442021
• Device Lot Number: 2109726
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/13/2023
• Event Location: Hospital
• Date Report to Manufacturer: 01/25/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/25/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 15695 DA
• Patient Sex: Male
• Patient Weight: 56 KG