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	06/03/2024
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 when using the bd vacutainer® fx 5mg 4mg blood collection tubes there was underfill of one tube.Additionally there was cap color variation in an unspecific number of tubes.There were no health consequences or impacts reported.
Additional Manufacturer Narrative
Defect color variation is being removed from mfr report # 1917413-2024-00614.A0908 - incorrect, inadequate or imprecise result or readings was removed from h.6 "additionally, there was cap color variation in an unspecific number of tubes." was removed from b.5.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: 05-jul-2024.Investigation summary: bd received 2 customer samples and no photos for investigation.The two samples were visually inspected with no issues being identified.The sample tubes were draw tested and all tubes were within specification limits.Additionally, one hundred (b)(4) retention samples from bd inventory were visually inspected with the hemogard closure assembly correctly assembled and placed on the tubes.A draw test was performed at the manufacturing site on 10 production lot in-house retention tubes.All tubes were within specification limits with no issues identified.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 mode underfill.Bd was not able to identify a root cause for the indicated failure mode.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 underfill of one tube.There were no 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: 19697415
• Report Number: 1917413-2024-00614
• Device Sequence Number: 7156134
• Product Code: JKA
• UDI-Device Identifier: 30382903689201
• UDI-Public: (01)30382903689201
• 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,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/09/2024

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: 03/31/2025
• Device Catalogue Number: 368920
• Device Lot Number: 3318946
• 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: 06/10/2024
• Supplement Date Received by Manufacturer: 07/15/2024
• Initial Report FDA Received Date: 07/08/2024
• Supplement Report FDA Received Date: 07/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/14/2023
• 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