MAUDE Adverse Event Report: BD CARIBE LTD. BD VACUTAINER® LUER-LOK¿ ACCESS DEVICE; BLOOD SPECIMEN COLLECTION DEVICE

Catalog Number	36490200
Medical Device Problem Code	Device Ingredient or Reagent Problem (2910)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/14/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported while using bd vacutainer® luer-lok¿ access device, hemolysis was seen in both green and pink top tubes.Exact tubes used is unknown.No adverse impact was reported regarding the patient or user.
Additional Manufacturer Narrative
A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported while using bd vacutainer® luer-lok¿ access device, hemolysis was seen in both green and pink top tubes.Exact tubes used is unknown.No adverse impact was reported regarding the patient or user.
Additional Manufacturer Narrative
Investigation summary bd had not received any samples for investigation.Therefore, twelve retained samples were visually inspected and yielded acceptable results.Since inspections are destructive, only twelve out of the forty-eight retained samples were tested.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: hemolysis.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.

• Brand Name: BD VACUTAINER® LUER-LOK¿ ACCESS DEVICE
• Common Device Name: BLOOD SPECIMEN COLLECTION DEVICE
• Manufacturer (Section D): BD CARIBE LTD.; road 31; k.m. 24.3; juncos PR
• Manufacturer (Section G): BD CARIBE LTD.; road 31; k.m. 24.3; juncos PR
• Manufacturer Contact: matt j. connor ; 7 loveton circle; sparks, MD 21152 ; 4103164000
• MDR Report Key: 21606459
• Report Number: 2618282-2025-00025
• Device Sequence Number: 9467130
• Product Code: JKA
• UDI-Device Identifier: 00382903649020
• UDI-Public: (01)00382903649020(11)240925(17)270731(10)4226369
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• 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,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/26/2025

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 Catalogue Number: 36490200
• Device Lot Number: 4226369
• 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: 02/14/2025
• Supplement Date Received by Manufacturer: 03/26/2025
• Initial Report FDA Received Date: 03/14/2025
• Supplement Report FDA Received Date: 04/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/25/2024
• 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