MAUDE Adverse Event Report: BECTON DICKINSON AND COMPANY/BECTON, DICKINSON & CO. BD VACUTAINER K2 EDTA 5.4 MG BLOOD COLLECTION TUBE; TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION

Model Number 367856

Device Problem Low Test Results (2458)

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

Event Date 12/21/2020

Event Type  malfunction  

Event Description

Patient had cbc w/differential blood collected into bd vacutainer k2 edta 5.4 mg tube (lot 0133332 exp 2021-09-30) and results revealed low wbc 2800/ul and absolute neutrophil count of 392 cells/ul.Repeat cbc w/differential was collected into different blood collection tube (different manufacturer) which revealed wbc 4100/ul and absolute neutrophil count of 2481 cells/ul.We have concern that this discrepancy is due to the bd vacutainer tube malfunctioning as this has additionally occurred in three additional patients, all with normalized wbc and neutrophil counts on same day or next day repeat labs collected into different manufacturer tube.Fda safety report id # (b)(4).

• Brand Name: BD VACUTAINER K2 EDTA 5.4 MG BLOOD COLLECTION TUBE
• Type of Device: TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION
• Manufacturer (Section D): BECTON DICKINSON AND COMPANY/BECTON, DICKINSON & CO.; franklin lakes NJ 07417
• MDR Report Key: 11100454
• MDR Text Key: 224855134
• Report Number: MW5098595
• Device Sequence Number: 1
• Product Code: JKA
• UDI-Device Identifier: 30382903678564
• UDI-Public: (01)30382903678564
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/28/2020

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 Expiration Date: 09/30/2021
• Device Model Number: 367856
• Device Catalogue Number: BD367835
• Device Lot Number: 0133332
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/30/2020
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 58 YR
• Patient Weight: 88