MAUDE Adverse Event Report: BECTON DICKINSON & CO (FRANKLIN LAKES) 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 Ingredient or Reagent Problem (2910)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/12/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation summary: bd received 3 photos for investigation regarding the reported defect of air bubbles trapped inside the gel of bd vacutainer® gel tubes.The evaluation of the photos confirmed the customer¿s indicated failure mode, air bubbles are seen in the gel in the tubes.This issue can occur during manufacturing processes such as mixing, pumping, and dispensing.Additionally, environmental and shipping conditions may influence the occurrence of air bubbles.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 mode: gel airbubbles.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 prior to using bd vacutainer® ppt¿ plasma preparation tube k2e 9.0 mg, 11 tubes contained gel air bubbles.There was no health impact or consequences reported.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d9.Returned to manufacturer: yes.H.3 device eval by manufacturer? yes.D9.Device available for eval?: 18-feb-2026.Investigation summary: bd received 11 samples and 3 photos for investigation.The evaluation of the samples and photos confirmed the indicated failure mode; air bubbles are seen in the gel in the tubes.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 mode: gel airbubbles-before use.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 prior to using bd vacutainer® ppt¿ plasma preparation tube k2e 9.0 mg, 11 tubes contained gel air bubbles.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 (FRANKLIN LAKES); 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BECTON, DICKINSON & CO. (BROKEN BOW); 150 south 1st avenue; broken bow NE 68822
• Manufacturer Contact: anand singh ; 1 becton drive; franklin lakes, NJ 07417 ; 2018475186
• MDR Report Key: 24273744
• Report Number: 1917413-2026-00047
• Device Sequence Number: 21337406
• Product Code: PJE
• UDI-Device Identifier: 30382903627883
• UDI-Public: (01)30382903627883(17)260331(10)5076181
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 02/24/2026

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: 03/31/2026
• Device Catalogue Number: 362788
• Device Lot Number: 5076181
• 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: 01/12/2026
• Supplement Date Received by Manufacturer: 02/24/2026
• Initial Report FDA Received Date: 02/05/2026
• Supplement Report FDA Received Date: 03/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/17/2025
• 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