MAUDE Adverse Event Report: BECTON DICKINSON & CO (FRANKLIN LAKES) BD VACUTAINER® FX 10MG 8MG BLOOD COLLECTION TUBES; TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION

Catalog Number	368921
Medical Device Problem Codes	Device Ingredient or Reagent Problem (2910); Improper Chemical Reaction (2952)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/16/2026
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
Report 1 of 3, it was reported while using bd vacutainer® fx 10mg 8mg blood collection tubes, hemolysis was seen with one sample after centrifugation and an unspecified number of tubes showed additive abnormality where the powder did not coat the entire tube wall but rather appeared clumpy.No adverse impact was reported regarding the patient or user.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d.9.Device available for evaluation: yes, d.9.Returned to manufacturer on: 17-mar-2025, h.3.Device eval by manufacturer? yes.Investigation summary: bd received 3 photos for investigation with respect to lot numbers 5076335 and 5197646.The photos were evaluated and hemolysis was observed; however additive abnormality was no observed.100 retained samples from both lots were inspected, with no issues being identified.Based on a review of the device history record for the incident lots, all product specifications and requirements for lot release were met.Complaints for sample quality were under statistical control for the month of january 2026.Additional testing is not indicated at this time.This complaint is unable to be confirmed with respect to lot numbers 5076335 and 5197646 for the indicated failure mode additive abnormality.This complaint has been confirmed for the lot 5076335, for the indicated failure mode hemolysis.Bd was unable to identify an exact root cause.Based on the low defect rate for the batch in question, no actions are planned at this time.Complaints received for this device and reported condition will continue to be tracked and trended.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 while using bd vacutainer® fx 10mg 8mg blood collection tubes, hemolysis was seen with one sample after centrifugation and an unspecified number of tubes showed additive abnormality where the powder did not coat the entire tube wall but rather appeared clumpy.No adverse impact was reported regarding the patient or user.

• Brand Name: BD VACUTAINER® FX 10MG 8MG BLOOD COLLECTION TUBES
• Common Device Name: TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION
• 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: 24377628
• Report Number: 1917413-2026-00098
• Device Sequence Number: 4838057
• Product Code: JKA
• UDI-Device Identifier: 30382903689218
• UDI-Public: (01)30382903689218(11)250317(17)260731(10)5076335
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K901449
• 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): 02/26/2026

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: 07/31/2026
• Device Catalogue Number: 368921
• Device Lot Number: 5076335
• 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: 01/19/2026
• Supplement Date Received by Manufacturer: 03/26/2026
• Initial Report FDA Received Date: 02/18/2026
• Supplement Report FDA Received Date: 04/11/2026
• 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