MAUDE Adverse Event Report: BECTON DICKINSON & CO (FRANKLIN LAKES) BD VACUTAINER® K2 EDTA (K2E) 10.8MG BLOOD COLLECTION TUBES; TUBES, VACUUM SAMPLE, WITH ANTICOAGULANT

Catalog Number	367863
Medical Device Problem Code	Coagulation in Device or Device Ingredient (1096)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/12/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the use of bd vacutainer® k2 edta (k2e) 10.8mg blood collection tube, one (1) tube appeared to be clotted.No adverse impact was reported regarding the patients or users.
Additional Manufacturer Narrative
E.1.Initial reporter facility name: (b)(6) hospital.There were multiple medical device types reported to be involved.The information for the additional device type is as follows d.2.B medical device type: jka d.2.A common device name: tubes, vials, systems, serum separators, blood collection g.4.There were multiple 510k numbers reported to be involved.The information is as follows: pma / 510(k)#: k213670; k231373 a device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

• Brand Name: BD VACUTAINER® K2 EDTA (K2E) 10.8MG BLOOD COLLECTION TUBES
• Common Device Name: TUBES, VACUUM SAMPLE, WITH ANTICOAGULANT
• Manufacturer (Section D): BECTON DICKINSON & CO (FRANKLIN LAKES); 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BECTON, DICKINSON & CO. (BROKEN BOW); 150 south 1st avenue; broken bow NE 68822
• Manufacturer Contact: anand singh ; 1 becton drive; franklin lakes, NJ 07417 ; 2018475186
• MDR Report Key: 25476957
• Report Number: 1917413-2026-00529
• Device Sequence Number: 9165334
• Product Code: GIM
• UDI-Device Identifier: 30382903678632
• UDI-Public: (01)30382903678632(11)250501(17)260731(10)5101420
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/17/2026

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 Expiration Date: 07/31/2026
• Device Catalogue Number: 367863
• Device Lot Number: 5101420
• 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: 05/12/2026
• Supplement Date Received by Manufacturer: 06/17/2026
• Initial Report FDA Received Date: 06/11/2026
• Supplement Report FDA Received Date: 06/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/01/2025
• 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