MAUDE Adverse Event Report: BECTON DICKINSON & CO (FRANKLIN LAKES) BD VACUTAINER® K2 EDTA (K2E) 7.2MG BLOOD COLLECTION TUBES; TUBES, VACUUM SAMPLE, WITH ANTICOAGULANT

Catalog Number	367861
Medical Device Problem Code	Short Fill (1575)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/14/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3: date of event is unknown.The date received by manufacturer has been used for this field.D2a.There were multiple medical device types reported to be involved.The information for the additional device type is as follows: jka.D2b.Common device name: tubes, vials, systems, serum separators, blood collection.There were multiple 510k numbers reported to be involved.The information is as follows: g.4.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.
Event or Problem Description
Report 1 of 2.It was reported while using bd vacutainer® k2 edta (k2e) 7.2mg blood collection tubes, 112 tubes underfilled.No adverse impact was reported regarding the patient or user.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d9: device available for evaluation: yes, h.3 device eval by manufacturer? yes, d9: returned to manufacturer on: 17-mar-2026.Investigation summary : bd received 1000 samples for lot 5197573 for investigation.The returned samples along with 100 retained samples from each lot were visually inspected and no issues were identified.Furthermore, functional draw volume testing was performed on 10 returned samples and 10 retained samples from each lot and all tubes tested were within specification limits.Based on a review of the device history record for the incident lots, all product specifications and requirements for lot release were met.This complaint has not been confirmed for the reported defect underfill.Bd was not able to identify a root cause for the indicated failure mode.Complaints received for this device and reported condition will continue to be tracked and trended.Our business team regularly reviews the collected data for the identification of emerging trends.
Event or Problem Description
Report 1 of 2.It was reported while using bd vacutainer® k2 edta (k2e) 7.2mg blood collection tubes, 112 tubes underfilled.No adverse impact was reported regarding the patient or user.

• Brand Name: BD VACUTAINER® K2 EDTA (K2E) 7.2MG 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: 24407880
• Report Number: 1917413-2026-00118
• Device Sequence Number: 8223385
• Product Code: GIM
• UDI-Device Identifier: 30382903678618
• UDI-Public: (01)30382903678618(11)250716(17)261130(10)5197573
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• 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,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/02/2026

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 Catalogue Number: 367861
• Device Lot Number: 5197573
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/26/2026
• Supplement Date Received by Manufacturer: 04/02/2026
• Initial Report FDA Received Date: 02/20/2026
• Supplement Report FDA Received Date: 04/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/16/2025
• 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