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

Catalog Number	367985
Medical Device Problem Code	Short Fill (1575)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/05/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There were multiple 510k numbers reported to be involved.The information is as follows: g.4.Pma / 510(k)#: k230855.Investigation summary: bd received 8 photos and 250 samples (lot 5142735) for investigation.The analysis of the customer photos showed multiple tubes with underfill defects for lot 5142735.However, collapsed tubes were not seen for lot 5142735 as the lot number was not visible in the photos.From the 250 customer samples, 30 were randomly selected and subjected to visual inspection for collapsed tubes, resulting in 3 failures for lot 5142735.The customer samples were not functionally tested for underfill as the sumter plant does not have a means to decontaminate the samples.For lot 5142735, 30 retained samples were visually inspected for all visual defects, and all samples passed.Additionally, a total of 20 retained samples were tested for draw functionality, and all tubes were within specification.Based on the review of batch records and investigation results, no definitive root cause from the manufacturing process was identified for the reported defects.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 been confirmed for the lot 5142735, for the indicated failure modes: collapse based on customer sample analysis and underfill based on customer photo analysis.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 while using bd vacutainer® sst¿, an unspecified number of tubes underfilled.Additionally, a non-reportable defect of collapsed tubes was also seen in an unspecified number of tubes.No adverse impact was reported regarding the patient or user.

• Brand Name: BD VACUTAINER® SST¿
• 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: matt j. connor ; 7 loveton circle; sparks, MD 21152 ; 4103164000
• MDR Report Key: 22965807
• Report Number: 1024879-2025-01191
• Device Sequence Number: 18407667
• Product Code: JKA
• UDI-Device Identifier: 30382903679851
• UDI-Public: (01)30382903679851(17)260430(10)5142735
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/14/2025

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 Expiration Date: 04/30/2026
• Device Catalogue Number: 367985
• Device Lot Number: 5142735
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/20/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/05/2025
• Initial Report FDA Received Date: 09/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/22/2025
• 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