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

Catalog Number	36490200
Medical Device Problem Codes	Fluid/Blood Leak (1250); Difficult to Insert (1316)
Health Effect - Clinical Code	Exposure to Body Fluids (1745)
Date of Event	05/12/2025
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
It was reported while using bd vacutainer® luer-lok¿ access device holder, tube push off is seen in an unspecified number of devices resulting in sample leakage and blood exposure.It is unclear the level of ppe worn by the healthcare worker nor if there was medical intervention.No adverse impact was reported regarding the patient or user.
Additional Manufacturer Narrative
Investigation summary bd had not received any samples or photos for investigation.A total of twelve retained samples were visually inspected, and six underwent functional tests.All units were found to comply with specification limits.Due to the destructive nature of the inspection, only twelve out of forty-eight retained samples were tested.A review of the device history record indicated a quality notification was raised for this issue.However, lot passed all in-process and final quality checks for lot release.This complaint has not been confirmed for the indicated failure mode: tube push off.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 while using bd vacutainer® luer-lok¿ access device holder, tube push off is seen in an unspecified number of devices resulting in sample leakage and blood exposure.It is unclear the level of ppe worn by the healthcare worker nor if there was medical intervention.No adverse impact was reported regarding the patient or user.

• Brand Name: BD VACUTAINER® LUER-LOK¿ ACCESS DEVICE HOLDER
• 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: 22176171
• Report Number: 2618282-2025-00050
• Device Sequence Number: 9520376
• Product Code: JKA
• UDI-Device Identifier: 00382903649020
• UDI-Public: (01)00382903649020(11)240922(17)270731(10)4226361
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): 07/07/2025

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: 4226361
• 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: 05/12/2025
• Supplement Date Received by Manufacturer: 07/07/2025
• Initial Report FDA Received Date: 06/10/2025
• Supplement Report FDA Received Date: 08/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/22/2024
• 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