MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY (BD) BD VACUTAINER® SST¿ II ADVANCE; BLOOD SPECIMEN COLLECTION DEVICE

Catalog Number	366882
Medical Device Problem Code	Device Ingredient or Reagent Problem (2910)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/21/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Multiple lot numbers: there were multiple lot numbers reported to be involved.The information for each additional lot number is as follows: d4.Medical device lot#: 4176076.D4.Medical device expiration date: 30-jun-2025.D4.Unique identifier (udi) #: (b)(4).H4.Device manufacture date: 24-jun-2024.D4.Medical device lot#: 4241846.D4.Medical device expiration date: 31-aug-2025.D4.Unique identifier (udi) #: (b)(4).H4.Device manufacture date: 28-aug-2024.Investigation summary: bd received five (5) photos and 300 samples from the following batches: 4176076 (100 samples), 4100744 (100 samples), and 4241846 (100 samples) for investigation.Evaluation of the photos indicated fibrin strands in the serum.All returned samples were visually inspected, and no additive defects related to fibrin were found.Additionally, 100 retained samples from each batch number: 4176076, 4100744 and 4241846 were visually inspected, and no additive defects related to fibrin were found.Complaints for sample quality are under statistical control for the month of january 2025.At this time, further testing is not indicated.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 lots: 4100744, 4176076 and 4241846, for the indicated failure mode: fibrin.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.Bd quality will continue to monitor sample quality complaints.
Event or Problem Description
It was reported while using bd vacutainer® sst¿ ii advance, 150 tubes across three lot numbers displayed fibrin.No adverse impact was reported regarding the patient or user.

• Brand Name: BD VACUTAINER® SST¿ II ADVANCE
• Common Device Name: BLOOD SPECIMEN COLLECTION DEVICE
• Manufacturer (Section D): BECTON, DICKINSON AND COMPANY (BD); belliver way; belliver industrial estate; plymouth ; UK
• Manufacturer (Section G): BECTON, DICKINSON AND COMPANY (BD); belliver way; belliver industrial estate; plymouth ; UK
• Manufacturer Contact: matt j. connor ; 7 loveton circle; sparks, MD 21152 ; 4103164000
• MDR Report Key: 21405217
• Report Number: 9617032-2025-00188
• Device Sequence Number: 15507608
• Product Code: JKA
• UDI-Device Identifier: 50382903668828
• UDI-Public: (01)50382903668828(11)240624(17)250630(10)4176076
• Combination Product (Y/N): N
• Initial Reporter Country: TU
• 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): 01/27/2025

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: 03/31/2025
• Device Catalogue Number: 366882
• Device Lot Number: 4100744
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/21/2025
• Initial Report FDA Received Date: 02/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/09/2024
• 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