MAUDE Adverse Event Report: BECTON, DICKINSON & CO., (BD) BD VACUTAINER® MULTIPLE SAMPLE LUER ADAPTER; BLOOD SPECIMEN COLLECTION DEVICE

Catalog Number	367290
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/29/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1.Initial reporter phone #: (b)(6).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 while using bd vacutainer® multiple sample luer adapter, blood leaked from the device.No adverse impact was reported regarding the patient or user.
Additional Manufacturer Narrative
Investigation summary bd had not received any samples for investigation.However, 10 retained samples were subjected to functional tests, using 30 tubes per needle.All the samples passed the tests, as there was no evidence of side pierced sleeves, poor sleeve recovery, or sleeve leakage during the draw.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: sleeve function.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 while using bd vacutainer® multiple sample luer adapter, blood leaked from the device.No adverse impact was reported regarding the patient or user.

• Brand Name: BD VACUTAINER® MULTIPLE SAMPLE LUER ADAPTER
• Common Device Name: BLOOD SPECIMEN COLLECTION DEVICE
• Manufacturer (Section D): BECTON, DICKINSON & CO., (BD); 1575 airport road; sumter SC 29153
• Manufacturer (Section G): BECTON, DICKINSON & CO., (BD); 1575 airport road; sumter SC 29153
• Manufacturer Contact: matt j. connor ; 7 loveton circle; sparks, MD 21152 ; 4103164000
• MDR Report Key: 21034252
• Report Number: 1024879-2024-01329
• Device Sequence Number: 13044861
• Product Code: JKA
• UDI-Device Identifier: 50382903672900
• UDI-Public: (01)50382903672900(11)220801(17)250731(10)2217247
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K991088
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/17/2025

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: 07/31/2025
• Device Catalogue Number: 367290
• Device Lot Number: 2217247
• 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: 12/09/2024
• Supplement Date Received by Manufacturer: 04/17/2025
• Initial Report FDA Received Date: 12/30/2024
• Supplement Report FDA Received Date: 05/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/01/2022
• 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