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	Missing Information (4053)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/08/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported prior to use of bd vacutainer® ppt¿ plasma preparation tubes k2e (edta) 9.0 mg, the box containing the tubes was different than usual and the label containing material number and lot number was missing.There was no health impact or consequences reported.
Event or Problem Description
It was reported prior to use of bd vacutainer® ppt¿ plasma preparation tubes k2e (edta) 9.0 mg, the box containing the tubes was different than usual and the label containing material number and lot number was missing.There was no health impact or consequences reported.
Additional Manufacturer Narrative
Investigation summary: bd received one photo for investigation.The photo was evaluated and shows product in a box that is not the way the product is package from the manufacturing site.Per manufacturing site procedure, the 100-unit trays will be placed into the corrugated case, two rows of five 100-unit trays will be placed into the case, for a total of ten trays per case.Eight of the trays will be facing to one end of the case; two trays will be reversed with tray facing toe opposite end of the case.This will ensure that trays are toward the outer edge of both ends of the case.No full case retentions are kept for this product.Based on a review of the device history record for the incident lot, all product specifications and requirements for lot release were met.Bd was able to confirm the customer¿s indicated failure mode of incorrect label(based on the photo provided); however, the product was not manufactured/packaged this way and the label applied is not per product specification from the manufacturing site.Root cause, while unknown is attributed to a failure after shipment from manufacturing site.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.

• 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: 22152909
• Report Number: 1917413-2025-00726
• Device Sequence Number: 9263075
• Product Code: PJE
• UDI-Device Identifier: 50382903627917
• UDI-Public: (01)50382903627917(11)250115(17)260131(10)5015917
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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): 06/30/2025

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: 01/31/2026
• Device Catalogue Number: 362791
• Device Lot Number: 5015917
• 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: 05/08/2025
• Supplement Date Received by Manufacturer: 06/30/2025
• Initial Report FDA Received Date: 06/05/2025
• Supplement Report FDA Received Date: 07/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/15/2025
• 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