MAUDE Adverse Event Report: BECTON DICKINSON & CO (FRANKLIN LAKES) BD VACUTAINER® BLOOD TRANSFER DEVICE; TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION

Catalog Number	364880
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	02/13/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during sample collection using bd vacutainer® blood transfer device holder, there was foreign matter inside the individual packaging.No adverse impact was reported regarding the patient or user.
Additional Manufacturer Narrative
A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d.9: device available for evaluation: yes.H.3 device eval by manufacturer? yes.D9: returned to manufacturer on: 16-mar-2026.G.4.Pma / 510(k)#: k991088.Investigation summary: 1 sample and 3 photos were provided for investigation.The device was sealed in its packaging blister showing small black dots.The images show the tyvek with product information including catalog number, batch number, and expiration date.The blister appears sealed, containing an unused btd device.Inside the blister, there appears to be what looks like small black dots.Additionally, forty-eight (48) retain samples were evaluated for foreign matter and zero units were found with the defect.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 been confirmed for the indicated failure mode: fm-unknown.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 that during sample collection using bd vacutainer® blood transfer device holder, there was foreign matter inside the individual packaging.No adverse impact was reported regarding the patient or user.

• Brand Name: BD VACUTAINER® BLOOD TRANSFER DEVICE
• Common Device Name: TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION
• Manufacturer (Section D): BECTON DICKINSON & CO (FRANKLIN LAKES); 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BD CARIBE LTD.; road 31; k.m. 24.3; juncos PR
• Manufacturer Contact: anand singh ; 1 becton drive; franklin lakes, NJ 07417 ; 2018475186
• MDR Report Key: 24628424
• Report Number: 2618282-2026-00041
• Device Sequence Number: 20981507
• Product Code: JKA
• UDI-Device Identifier: 00382903648801
• UDI-Public: (01)00382903648801(11)250811(17)280630(10)5160006
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K222478
• 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,Followup
• Report Date (Section B): 04/13/2026

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: 364880
• Device Lot Number: 5160006
• 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: 02/20/2026
• Supplement Date Received by Manufacturer: 04/13/2026
• Initial Report FDA Received Date: 03/18/2026
• Supplement Report FDA Received Date: 04/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/11/2025
• 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