MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (BROKEN BOW) BD VACUTAINER® PPT¿ PLASMA PREPARATION TUBES K2E (EDTA) 9.0 MG; BLOOD/PLASMA COLLECTION DEVICE FOR DNA TESTING

Catalog Number	362791
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/22/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported during use of bd vacutainer® ppt¿ plasma preparation tubes k2e (edta) 9.0 mg, 10 tubes exhibited poor plasma (floaties in the plasma).There was no health impact or consequences reported.
Event or Problem Description
It was reported during use of bd vacutainer® ppt¿ plasma preparation tubes k2e (edta) 9.0 mg, 10 tubes exhibited poor plasma (floaties in the plasma).There was no health impact or consequences reported.
Additional Manufacturer Narrative
Investigation summary bd had not received samples or photos for evaluation.Therefore, 100 retention samples of the incident lot were selected from bd inventory for visual inspection and no issues were observed.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.Complaints for sample quality were not under statistical control for the month of january 2025, therefore additional testing was performed.Factors that may contribute to poor plasma were evaluated through a clinical study to verify the design of the device met it¿s intended use.Customer returned samples and retention samples were clinically tested for the reported defect along with non-complaint control tubes.After collection of venous blood into the study tubes in a randomized order, tubes were mixed by inversions and centrifuged to obtain plasma according to the product instructions for use (ifu).Each tube was inspected for selected visual observations.The visual observations included complete fill, presence of particles in plasma, and barrier formation.All study tubes demonstrated complete fill and complete barrier formation.A trace amount of particles in plasma was observed in all study tubes immediately after centrifugation.Additionally, it was observed that the number of particles in the plasma increased when the tubes were mixed in both non-complaint and evaluation tubes.There was no evidence to suggest the particles consisted of separation gel.It is important to note that separated plasma samples will have a gradient of cells and platelets present after centrifugation.The product ifu indicates that following centrifugation some lymphocytes will remain at the plasma/gel interface.Plasma sample quality may further be impacted by the presence of cellular debris/clumps, microclots, or fibrin.These may also present in the form of white particulate matter (wpm), which is understood to be composed predominantly of platelets, with white blood cells and cellular debris including fragments and granules from white blood cells, and occasional fibrin strands.These are not unexpected observations in separated plasma samples.Overall, the clinical study demonstrated that the products performed as expected and we were unable to determine any manufacturing defect.This complaint is unable to be confirmed for the indicated failure mode poor plasma.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.Bd quality will continue to monitor sample quality complaints.

• Brand Name: BD VACUTAINER® PPT¿ PLASMA PREPARATION TUBES K2E (EDTA) 9.0 MG
• Common Device Name: BLOOD/PLASMA COLLECTION DEVICE FOR DNA TESTING
• 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: 21403022
• Report Number: 1917413-2025-00126
• Device Sequence Number: 13107021
• Product Code: PJE
• UDI-Device Identifier: 50382903627917
• UDI-Public: (01)50382903627917(11)240411(17)250430(10)4102175
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K972075
• 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,Followup
• Report Date (Section B): 05/22/2025

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: 04/30/2025
• Device Catalogue Number: 362791
• Device Lot Number: 4102175
• 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: 01/23/2025
• Supplement Date Received by Manufacturer: 05/22/2025
• Initial Report FDA Received Date: 02/18/2025
• Supplement Report FDA Received Date: 06/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/11/2024
• 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