MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (BROKEN BOW) BD VACUTAINER® SODIUM HEPARINN (NH) 158 U.S.P. UNITS BLOOD COLLECTION TUBES; BLOOD SPECIMEN COLLECTION DEVICE

Catalog Number	366480
Medical Device Problem Code	Device Ingredient or Reagent Problem (2910)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/16/2025
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 prior to using bd vacutainer® sodium heparin (nh) 158 u.S.P.Units blood collection tubes, there was an additive abnormality (clumped) in 200 tubes.No adverse impact was reported regarding the patient or user.
Additional Manufacturer Narrative
The following fields have been updated with corrected and/or additional information.D9: device available for evaluation: yes.H3: device eval by manufacturer? yes.D9: returned to manufacturer on: 24-april-2025.Investigation summary: bd received 12 samples and one photo for investigation.The evaluation of the returned samples and photo shows the additive is in the form of a disc in the bottom of the tube.The additive for this catalog number, 366480, is freeze dried per specification.This is the correct appearance for the process.No issues were identified with the returned samples and photo.Additionally, 100 retained samples were visually inspected, and no issues were identified.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 not been confirmed for the indicated failure mode: additive abnormality.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® sodium heparinn (nh) 158 u.S.P.Units blood collection tubes, there was an additive abnormality (clumped) in 200 tubes.No adverse impact was reported regarding the patient or user.

• Brand Name: BD VACUTAINER® SODIUM HEPARINN (NH) 158 U.S.P. UNITS BLOOD COLLECTION TUBES
• Common Device Name: BLOOD SPECIMEN COLLECTION DEVICE
• 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: 22032183
• Report Number: 1917413-2025-00632
• Device Sequence Number: 18512649
• Product Code: JKA
• UDI-Device Identifier: 30382903664802
• UDI-Public: (01)30382903664802(11)230810(17)250831(10)3222704
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: NA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/24/2025

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: 08/31/2025
• Device Catalogue Number: 366480
• Device Lot Number: 3222704
• 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: 04/16/2025
• Supplement Date Received by Manufacturer: 06/24/2025
• Initial Report FDA Received Date: 05/15/2025
• Supplement Report FDA Received Date: 06/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/10/2023
• 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