MAUDE Adverse Event Report: BECTON DICKINSON AND COMPANY BD VACUTAINER SPS TUBE; TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION

Catalog Number 364960

Device Problem Microbial Contamination of Device (2303)

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

Event Date 07/19/2021

Event Type  malfunction  

Event Description

Bd sps yellow top tubes are used for sterility testing of cellular therapy products.Products collected from (b)(6) 2021 until (b)(6) 2021 showed positive sterilities of gram positive rods.After sending the blank sps tube lot for sterility testing, gram positive rods were also found.The tubes have caused reporting of multiple false positive results due to it not being sterile; 13 product samples collected from (b)(6) 2021-(b)(6) 2021 have tested positive for bacillus sp and/or coryneform bacteria.Fda safety report id# (b)(4).

• Brand Name: BD VACUTAINER SPS TUBE
• Type of Device: TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION
• Manufacturer (Section D): BECTON DICKINSON AND COMPANY
• MDR Report Key: 12365395
• MDR Text Key: 268287667
• Report Number: MW5103482
• Device Sequence Number: 1
• Product Code: JKA
• 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: 08/22/2021
• 13 Devices were Involved in the Event: 1 2 3 4 5 6 7 8 9 10 11 12 13

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 11/30/2021
• Device Catalogue Number: 364960
• Device Lot Number: 0316301
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1