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

Catalog Number	364606
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	02/18/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Report 1 of 2: it was reported prior to using bd vacutainer® acd solution a blood collection tubes, an unspecified amount of tubes were broken and others had foreign matter inside the tube.No adverse impact was reported regarding the patient or user.
Additional Manufacturer Narrative
Investigation summary: bd received samples from catalog 364606, specifically from lot numbers 5225442 and 5136452, for investigation.Among the materials provided, a total of 100 samples and 17 photos were submitted.Evaluation of the photos revealed broken tubes and foreign material that appeared to be a broken piece of glass.However, no photos were received showing the tray or the case in which the product was packed.The 100 retained samples from both lots were visually inspected, and no issues were identified.Based on a review of the device history record for the incident lots, all product specifications and requirements for lot release were met.This complaint has been confirmed for the lot 5136452, for the indicated failure modes: damaged and foreign matter - non-biological.This complaint has been confirmed for the lot 5225442, for the indicated failure modes: damaged and foreign matter - non-biological.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.

• Brand Name: BD VACUTAINER® ACD SOLUTION A BLOOD COLLECTION TUBES
• 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): BECTON, DICKINSON & CO. (BROKEN BOW); 150 south 1st avenue; broken bow NE 68822
• Manufacturer Contact: anand singh ; 1 becton drive; franklin lakes, NJ 07417 ; 2018475186
• MDR Report Key: 24623786
• Report Number: 1917413-2026-00183
• Device Sequence Number: 21071205
• Product Code: JKA
• UDI-Device Identifier: 30382903646068
• UDI-Public: (01)30382903646068(17)270831(10)5225442
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: BK210649
• 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
• Report Date (Section B): 03/02/2026

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: 364606
• Device Lot Number: 5225442
• 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: 02/18/2026
• Initial Report FDA Received Date: 03/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/01/2025
• 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