MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (BROKEN BOW) BD VACUTAINER® FX 5MG 4MG BLOOD COLLECTION TUBES; EVACUATED BLOOD COLLECTION TUBE IVD, ANTICOAGULANT/ANTIGLYCOLYTIC

Catalog Number	368920
Medical Device Problem Codes	Incorrect, Inadequate or Imprecise Result or Readings (1535); Short Fill (1575)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/18/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation summary: bd had not received samples or photos for investigation.Therefore, 100 retention samples from bd inventory were evaluated by visual examination and 10 sample functional testing.No issues were observed relating to underfill as all samples met specifications.Upon review of the complaint information, it was determined a clinical investigation regarding erroneous results was not required as the customer confirmed clearly underfilled tube was analyzed for blood glucose.Overfilling or under filling of tubes will result in an incorrect blood-to-additive ratio and may lead to incorrect analytic results or poor product performance.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.This complaint is unable to be confirmed for the indicated failure modes underfill and erroneous results-glucose.Bd was not able to identify a definitive root cause for the indicated failure modes.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.
Event or Problem Description
It was reported when using the bd vacutainer® fx 5mg 4mg blood collection tubes, there was one device with low blood fill volume.The tube was tested for glucose and erroneous results were reported; however, no treatment was changed based on the results.There were no other health consequences or impacts reported.

• Brand Name: BD VACUTAINER® FX 5MG 4MG BLOOD COLLECTION TUBES
• Common Device Name: EVACUATED BLOOD COLLECTION TUBE IVD, ANTICOAGULANT/ANTIGLYCOLYTIC
• 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: jo doyka ; 7 loveton circle; sparks, MD 21152 ; 4103164000
• MDR Report Key: 20688413
• Report Number: 1917413-2024-01059
• Device Sequence Number: 12936866
• Product Code: JKA
• UDI-Device Identifier: 30382903689201
• UDI-Public: (01)30382903689201(11)240214(17)250630(10)4045339
• 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
• Report Date (Section B): 10/29/2024

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: 06/30/2025
• Device Catalogue Number: 368920
• Device Lot Number: 4045339
• 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: 10/18/2024
• Initial Report FDA Received Date: 11/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/14/2024
• 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