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

Catalog Number	362788
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/22/2025
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 that before using the bd vacutainer® ppt¿ plasma preparation tube k2e 9.0 mg, white foreign matter was observed in 200 tubes.No adverse impact was reported regarding the patient or user.
Additional Manufacturer Narrative
The following fields were updated with corrected information due to additional information received: b3.Describe event or problem: "report 1 of 3: it was reported prior to use of bd vacutainer® ppt¿ plasma preparation tube k2e 9.0 mg,, 1 tube contained foreign matter (clumps).Foreign matter outside of the tube was also reported on tube and embedded in the shield.Wrinkled tube labels was also reported.There was no health impact or consequences reported." d4.Medical device expiration date: 31-oct-2025.D4.Unique identifier (udi) #: (b)(4).D9: device available for evaluation: yes.D9: returned to manufacturer on: 24-oct-2025.H4.Device manufacture date: 14-oct-2024.
Event or Problem Description
Report 1 of 3: it was reported prior to use of bd vacutainer® ppt¿ plasma preparation tube k2e 9.0 mg,, 1 tube contained foreign matter (clumps).Foreign matter outside of the tube was also reported on tube and embedded in the shield.Wrinkled tube labels was also reported.There was no health impact or consequences reported.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d9: device available for evaluation: yes.H.3 device eval by manufacturer? yes.D9: returned to manufacturer on: 24-oct-2025.Investigation summary: bd received samples and photos for investigation.Among the 42 samples received, 13 were sent for further inspection.All samples were inspected for foreign material, embedded foreign material(fm) in the tube and shield, as well as incorrect or missing label information, including missing, wrinkled, or lifting labels.Additionally, the 13 samples underwent visual inspection for embedded foreign material in the tube, embedded foreign material in the shield, and foreign material in the tube and under the tube label.6 samples were confirmed with embedded fm in the tube, one sample with embedded fm in the shield, and 6 samples with fm in the tube and under the tube label.The 11 photos were evaluated and demonstrate the customer¿s indicated failure modes.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: foreign matter - unknown, incorrect/missing label information and molding defect(embedded fm in tube and shield).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
Report 1 of 3: it was reported prior to use of bd vacutainer® ppt¿ plasma preparation tube k2e 9.0 mg,, 1 tube contained foreign matter (clumps).Foreign matter outside of the tube was also reported on tube and embedded in the shield.Wrinkled tube labels was also reported.There was no health impact or consequences reported.

• Brand Name: BD VACUTAINER® PPT¿ PLASMA PREPARATION TUBE K2E 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: 23115275
• Report Number: 1917413-2025-01328
• Device Sequence Number: 7741452
• Product Code: PJE
• UDI-Device Identifier: 30382903627883
• UDI-Public: (01)30382903627883(17)251031(10)4288981
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,Followup
• Report Date (Section B): 01/09/2026

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: 10/31/2025
• Device Catalogue Number: 362788
• Device Lot Number: 4288981
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/25/2025
• Supplement Date Received by Manufacturer: 10/14/2025; 01/09/2026
• Initial Report FDA Received Date: 09/22/2025
• Supplement Report FDA Received Date: 11/11/2025; 01/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/14/2024
• 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