MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY (BD) BD VACUTAINER® K2 EDTA (K2E) PLUS BLOOD COLLECTION TUBES; BLOOD SPECIMEN COLLECTION DEVICE

Catalog Number	366643
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/12/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D4.Medical device lot#: unknown.D4.Medical device expiration date: unknown.H4.Device manufacture date: unknown.D2b.Medical device type: there were multiple medical device types reported to be involved.The information for the additional device type is as follows: jka.There were multiple 510k numbers reported to be involved.The information for the additional 510k is as follows: g4.Pma / 510(k)#: k213670, k231373.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported when using the bd vacutainer® k2 edta (k2e) plus blood collection tubes there was erroneous hba1c results on two devices.No adverse impact was reported regarding the patient or user.
Additional Manufacturer Narrative
Investigation summary : bd had not received samples or photos for evaluation.Additionally, bd was unable to determine the specific lot number associated with this complaint; therefore, a review of the device history record could not be conducted.Bd was unable to duplicate the customer¿s indicated failure mode (erroneous results-hba1c) because the lot number is unknown.The affected lot(s) must be specified in order to perform clinical testing.Additionally the customer indicated the issue of 2 high hba1c results was due to the health professional not mixing the specimen adequately following collection.The bd instructions for use (ifu) state "for proper additive performance, immediately and gently invert edta tubes 8¿10 times.Do not shake.Vigorous mixing may cause foaming or hemolysis.In tubes with anticoagulants, inadequate or delayed mixing may result in platelet clumping, clotting and/or incorrect test results." this complaint is unable to be confirmed for the indicated failure erroneous results-hba1c.If additional information is made available, this complaint will be reopened to assess the level of investigation needed.Complaints received for this device and reported condition will continue to be tracked and trended.Our business team regularly reviews the collected data for identification of emerging trends.
Event or Problem Description
It was reported when using the bd vacutainer® k2 edta (k2e) plus blood collection tubes there was erroneous hba1c results on two devices.No adverse impact was reported regarding the patient or user.

• Brand Name: BD VACUTAINER® K2 EDTA (K2E) PLUS BLOOD COLLECTION TUBES
• Common Device Name: BLOOD SPECIMEN COLLECTION DEVICE
• Manufacturer (Section D): BECTON, DICKINSON AND COMPANY (BD); belliver way; belliver industrial estate; plymouth ; UK
• Manufacturer (Section G): BECTON, DICKINSON AND COMPANY (BD); belliver way; belliver industrial estate; plymouth ; UK
• Manufacturer Contact: matt j. connor ; 7 loveton circle; sparks, MD 21152 ; 4103164000
• MDR Report Key: 22666188
• Report Number: 9617032-2025-01389
• Device Sequence Number: 17063376
• Product Code: GIM
• UDI-Device Identifier: 30382903666431
• UDI-Public: (01)30382903666431
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: BK230980
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/25/2025

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
• Operator of Device: Other
• Device Catalogue Number: 366643
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/12/2025
• Supplement Date Received by Manufacturer: 11/25/2025
• Initial Report FDA Received Date: 07/30/2025
• Supplement Report FDA Received Date: 11/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown