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	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/22/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D4.Medical device expiration date: unknown.H4.Device manufacture date: unknown.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 that before using one (1) bd vacutainer® multiple sample luer adapter, there was a blade present in the packaging of the unit.No adverse impact was reported regarding the patient or user.
Additional Manufacturer Narrative
The following fields were updated due to additional information: there were multiple 510k numbers reported to be involved.The information is as follows: g.4.Pma / 510(k)#: k243649.Investigation summary: bd had not received samples, but 2 photos were provided for investigation.The photos were reviewed and the indicated failure mode for foreign matter was observed.Bd was unable to determine the specific lot number associated with this complaint; therefore, a review of the device history record could not be conducted.This complaint has been confirmed for the indicated failure mode foreign matter.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 that before using one (1) bd vacutainer® multiple sample luer adapter, there was a blade present in the packaging of the unit.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: anand singh ; 1 becton drive; franklin lakes, NJ 07417 ; 2018475186
• MDR Report Key: 23596832
• Report Number: 1024879-2025-01852
• Device Sequence Number: 21451939
• Product Code: JKA
• UDI-Device Identifier: 30382903672906
• UDI-Public: (01)30382903672906
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• 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,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/16/2026

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 Catalogue Number: 367290
• Device Lot Number: UNKNOWN
• 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: 10/22/2025
• Supplement Date Received by Manufacturer: 03/16/2026
• Initial Report FDA Received Date: 11/19/2025
• Supplement Report FDA Received Date: 04/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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