MAUDE Adverse Event Report: BECTON, DICKINSON & CO., (BD) BD VACUTAINER® SERUM; BLOOD SPECIMEN COLLECTION DEVICE

Catalog Number	367820
Medical Device Problem Code	Excessive Heating (4030)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/29/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E.1 initial reporter phone #: (b)(6).Investigation summary: catalog number: 367820, batch number: 5211614.The device history record was reviewed with no issues being identified.There were no related quality notifications.All process and final inspections comply with specification requirements.One customer photo was received.The photo contained information on what tubes were received by the customer.Therefore, bd cannot confirm the reported defect based on customer photo analysis.No retain tests cannot be performed for this defect type.The root cause from this defect is not related to the manufacturing process.Based on an evaluation of severity and frequency, it was determined that no corrective action is required at this time.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 monitoring of current trends.
Event or Problem Description
It was reported that prior to using bd vacutainer® serum, an unspecified number of tubes exhibited temperature excursion during transport.No adverse impact was reported regarding the patient or user.
Additional Manufacturer Narrative
Investigation summary: bd received one photo for investigation.The photo was reviewed and the indicated failure mode for storage - tube/no sample with the incident lot was not observed.Retention samples were unable to be tested for this defect type.Based on a review of the device history record for the incident lot, all product specifications and requirements for lot release were met.There were no related quality issues during manufacturing of the product.This complaint is unable to be confirmed for the indicated failure mode storage - tube/no sample.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 identification of emerging trends.
Event or Problem Description
It was reported that prior to using bd vacutainer® serum, an unspecified number of tubes exhibited temperature excursion during transport.No adverse impact was reported regarding the patient or user.
Event or Problem Description
It was reported that prior to using bd vacutainer® serum, an unspecified number of tubes exhibited temperature excursion during transport.No adverse impact was reported regarding the patient or user.
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® serum / cat blood collection tubes specific malfunction: tubes (without sample) stored at the wrong 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® SERUM
• Common Device Name: BLOOD SPECIMEN COLLECTION DEVICE
• Manufacturer (Section D): BECTON, DICKINSON & CO., (BD); 1575 airport road; sumter SC 29153
• Manufacturer (Section G): BECTON, DICKINSON & CO., (BD); 1575 airport road; sumter SC 29153
• Manufacturer Contact: anand singh ; 1 becton drive; franklin lakes, NJ 07417 ; 2018475186
• MDR Report Key: 23408422
• Report Number: 1024879-2025-01669
• Device Sequence Number: 8919152
• Product Code: JKA
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: BK050036
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative,Distributor
• 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: 367820
• Device Lot Number: 5211614
• 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: 09/29/2025
• Supplement Date Received by Manufacturer: 11/18/2025; Not provided
• Initial Report FDA Received Date: 10/28/2025
• Supplement Report FDA Received Date: 12/04/2025; 09/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/30/2025
• 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