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	04/14/2025
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 23 samples and one photo for investigation.The 23 customer samples underwent multiple inspections.Out of these, four samples failed the visual inspection due to improper assembly.In the inspection for collapsed tubes, 14 samples failed.When checked for molded part defects, 22 samples failed.A further visual inspection for foreign matter (fm) resulted in 5 samples failing, and another inspection for damages saw 14 samples failing.Ten customer samples were inspected for brittleness, with none failing.Five customer samples underwent functional tests for low or no draw, all tubes tested were within specification.The customer photo revealed defects such as missing stoppers, sunken sides, deformed stoppers and low sample draw volume.On the retained side, 30 samples were inspected for any visual defect, with none failing.Twenty retained samples underwent functional tests for low or no draw, all tubes tested were within specification.Ten retained samples were inspected for brittleness, with none failing.Based on a review of the device history record for the incident lot, all product specifications and requirements for lot release were met.This complaint has been confirmed for the indicated failure modes: collapse, damaged, foreign matter, improper assembly, molding defect and underfill.No definitive root cause could be established for the reported defect.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.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: 22153731
• Report Number: 1024879-2025-00794
• Device Sequence Number: 20790705
• Product Code: JKA
• UDI-Device Identifier: 30382903679851
• UDI-Public: (01)30382903679851(11)240819(17)250731(10)4232450
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 05/29/2025

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: 07/31/2025
• Device Catalogue Number: 367985
• Device Lot Number: 4232450
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/02/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/13/2025
• Initial Report FDA Received Date: 06/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/19/2024
• 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