MAUDE Adverse Event Report: BECTON DICKINSON VACUTAINER TUBES; TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Use of Device Problem (1670); Expiration Date Error (2528)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  malfunction  

Event Description

The medical office located at (b)(6) had been using expired tubes on their patients in order to collect blood specimens.The pictures show tubes expired on 2020 - 2021.The results from these tubes are not accurate and represents a problem for the patients.I have pictures of these expired tubes that were taken on (b)(6) 2022.When you enter this office go to your left and as soon as you make a right, the first door on your right is where these expired tubes are.This is only one issue or violation this company makes, everybody in this office talks loudly and everybody can hear all the issues and how badly the office is run."if somebody comes here, this is office i'll be shut down for sure" besides the expired tubes, another issue is dr.(b)(6) uses the same diagnosis codes on almost all his patients (blood work) in order to get reimbursed by (b)(6) (this is (b)(6) fraud).This office has his own laboratory and process all their specimens only for (b)(6) patients.The dx codes are: d64.9 e11.9 e78.5 e03.9 e55.9 i10 is a very unprofessional od that is putting dx codes on his patients and their charts, that will affect the patients in the future.You can find the laboratory orders in his office or in the laboratory office ((b)(6)) this medical office and this od need to be investigated and reprimand.This problem had been going on for more than 5 years and i am sick of listening to the patients complain about this and other issues, and nobody does anything all the staff keep their mouth shut because they don't want to lose their jobs and also because they are afraid of retaliation.(b)(6).Fda safety report id #:(b)(4).

• Brand Name: VACUTAINER TUBES
• Type of Device: TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION
• Manufacturer (Section D): BECTON DICKINSON
• MDR Report Key: 13584431
• MDR Text Key: 286431928
• Report Number: MW5107634
• Device Sequence Number: 1
• Product Code: JKA
• 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: 02/18/2022
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2020
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1