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

Catalog Number	36488000
Medical Device Problem Code	Volume Accuracy Problem (1675)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/06/2025
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
Report 2 of 3: it was reported while using bd vacutainer® blood transfer device, one device was unable to dispense blood.No adverse impact was reported regarding the patient or user.
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: 05-dec-2025.Investigation summary: bd received 3 samples and 6 photos were provided for investigation.The photos were reviewed and the indicated failure mode for clog was not observed.The photos show three (3) btd devices with blood remaining in the red hub and two (2) tyvek showing batch number 5037068.The customer samples were analyzed by microscopic analysis and it was observed that the hub and needle lumen were unobstructed; however, residual blood deposits were present.Additionally, 48 retention samples from bd inventory, were visually evaluated for sleeve assembly, pierced sleeve, defective sleeve, clogged cannula and foreign matter in non-patient(np) cannula with no defects observed.Furthermore, 12 of the retain samples were functionally evaluated for leakage and all samples tested within specification requirements.Based on a review of the device history record for the incident lot, all product specifications and requirements for lot release were met.There were no related quality issues during manufacturing of the product.This complaint is unable to be confirmed for the indicated failure mode clog.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
Report 2 of 3: it was reported while using bd vacutainer® blood transfer device, one device was unable to dispense blood.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: 23728716
• Report Number: 2618282-2025-00138
• Device Sequence Number: 9071904
• Product Code: JKA
• UDI-Device Identifier: 00382903648801
• UDI-Public: (01)00382903648801(11)250317(17)280131(10)5037068
• 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): 03/10/2026

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: 36488000
• Device Lot Number: 5037068
• 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: 11/07/2025
• Supplement Date Received by Manufacturer: 03/10/2026
• Initial Report FDA Received Date: 12/05/2025
• Supplement Report FDA Received Date: 03/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/17/2025
• 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