MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (BROKEN BOW) BD VACUTAINER® K2 EDTA (K2E) 10.8MG BLOOD COLLECTION TUBES; TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION

Catalog Number	367899
Medical Device Problem Code	Excessive Heating (4030)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/25/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D2b.There were multiple medical device types reported to be involved.The information for the additional device type is as follows: gim.There were multiple 510k numbers reported to be involved.The information for the additional 510k is as follows: g4.Pma / 510(k)#: k213670.G4.Pma / 510(k)#: k231373.D4.Medical device expiration date: unknown.H4.Device manufacture date: unknown.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 prior to use of bd vacutainer® k2 edta (k2e) 10.8mg blood collection tubes, an unspecified number of tubes were stored at incorrect temperature.There was no health impact or consequences reported.
Event or Problem Description
It was reported prior to use of bd vacutainer® k2 edta (k2e) 10.8mg blood collection tubes, an unspecified number of tubes were stored at incorrect temperature.There was no health impact or consequences reported.
Additional Manufacturer Narrative
Investigation summary: bd had not received any samples for investigation.The device history records could not be reviewed as the lot number is unknown.This complaint has not been confirmed for the indicated failure mode: storage.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.Our business team regularly reviews the collected data for the identification of emerging trends.
Event or Problem Description
It was reported prior to use of bd vacutainer® k2 edta (k2e) 10.8mg blood collection tubes, an unspecified number of tubes were stored at incorrect temperature.There was no health impact or consequences reported.
Additional Manufacturer Narrative
This supplemental mdr is submitted to document that bd will no longer consider the specific malfunction identified below to be a reportable mdr malfunction for the specified product family.Consistent with fda's "medical device reporting for manufacturers" guidance (november 8, 2016, section 2.15), bd determined that this issue has not caused or contributed to a death or serious injury in the previous two years and that the likelihood of a death or serious injury occurring as a result is remote.Bd previously notified fda of this determination on january 8, 2026.Product family: bd vacutainer® edta blood collection tubes.Specific malfunction: samples not stored at proper temperature.This mdr is being submitted as a representative notification for the product family and specific malfunction identified above and applies to all applicable catalog numbers within that product family associated with this issue.This determination applies only to the issue identified above when it occurs independently and does not otherwise meet mdr reporting requirements.Bd will continue to submit mdrs for reportable deaths, serious injuries, and reportable malfunctions, including events involving multiple event types where mdr reporting criteria are met.Future occurrences of this issue will no longer be submitted as standalone malfunction mdrs.Bd will continue to monitor complaint and adverse event data related to this issue and will reassess mdr reportability should new information indicate that reporting criteria may be met.

• Brand Name: BD VACUTAINER® K2 EDTA (K2E) 10.8MG BLOOD COLLECTION TUBES
• Common Device Name: TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION
• Manufacturer (Section D): BECTON, DICKINSON & CO. (BROKEN BOW); 150 south 1st avenue; broken bow NE 68822
• Manufacturer (Section G): BECTON, DICKINSON & CO. (BROKEN BOW); 150 south 1st avenue; broken bow NE 68822
• Manufacturer Contact: matt j. connor ; 7 loveton circle; sparks, MD 21152 ; 4103164000
• MDR Report Key: 22977606
• Report Number: 1917413-2025-01215
• Device Sequence Number: 13148977
• Product Code: JKA
• 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,Followup
• Report Date (Section B): 09/03/2026

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: 367899
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/08/2025
• Supplement Date Received by Manufacturer: 10/17/2025; Not provided
• Initial Report FDA Received Date: 09/05/2025
• Supplement Report FDA Received Date: 11/13/2025; 09/15/2026
• 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