MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY BD BACTEC PLUS AEROBIC/F CULTURE VIALS; SYSTEM, BLOOD CULTURING

Model Number 442023

Patient Problem Insufficient Information (4580)

Event Date 08/31/2023

Event Type  malfunction  

Event Description

Situation - aerobic blood culture bottles are coming to 9wp damaged.Sterile process is not maintained with these bottles.Background - staff on 9wp noticed multiple blue top blood culture bottles are being found damaged with the sterile top being indented.Staff will remove the cap off these devices and noticed the gray center is inverted.Analysis- these bottles should not be used for blood cultures as we do not know if there was a breach in sterile process, needles are not able to be used to inject blood into the bottles due to not having a flat service.Lot number 3102697.Exp date [redacted date].Not sure if other lot numbers are involved.Reports this happening over the weekend as well but staff did not save bottles or record lot numbers.Recommendation - value analysis and/or materials management collect device and determine what needs to happen further.Manufacturer response for blood culture bottles, aerobic blood culture bottle (per site reporter).[redacted date] - emailed bd complaints.Bd case (b)(4).

• Brand Name: BD BACTEC PLUS AEROBIC/F CULTURE VIALS
• Type of Device: SYSTEM, BLOOD CULTURING
• Manufacturer (Section D): BECTON, DICKINSON AND COMPANY; 1 becton dr; franklin lakes NJ 07417
• MDR Report Key: 18255446
• MDR Text Key: 329587382
• Report Number: 18255446
• 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: Nurse
• Type of Report: Initial
• Report Date: 10/04/2023

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 Operator: Health Professional
• Device Model Number: 442023
• Device Catalogue Number: 442023
• Device Lot Number: 3102697
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/06/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/04/2023
• Event Location: Hospital
• Date Report to Manufacturer: 12/04/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/04/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1