MAUDE Adverse Event Report: BD CARIBE LTD. SEE H.11; BLOOD SPECIMEN COLLECTION DEVICE

Catalog Number	36490200
Medical Device Problem Codes	Leak/Splash (1354); Short Fill (1575); Improper Chemical Reaction (2952)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/02/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported while using bd vacutainer® luer-lok¿ access device holder with pre-attached multiple sample adapter, the hub of an unspecified number of devices does not screw on correctly resulting in sample leakage, loss of vacuum and hemolysis.No adverse impact was reported regarding the patient or user.
Additional Manufacturer Narrative
B3: date of event is unknown.The date received by manufacturer has been used for this field.D1: medical device brand name: bd vacutainer® luer-lok¿ access device holder with pre-attached multiple sample adapter.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Additional Manufacturer Narrative
Investigation summary: bd had not received samples or photos for evaluation.Therefore, a total of twelve retained samples underwent visual inspection, and six retained samples underwent functional tests.All units passed the inspections.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 modes: clog, inability to attach as intended and sleeve leakage.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.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 with pre-attached multiple sample adapter, the hub of an unspecified number of devices does not screw on correctly resulting in sample leakage, loss of vacuum and hemolysis.No adverse impact was reported regarding the patient or user.

• Brand Name: SEE H.11
• 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: 22119566
• Report Number: 2618282-2025-00044
• Device Sequence Number: 4122474
• Product Code: JKA
• UDI-Device Identifier: 00382903649020
• UDI-Public: (01)00382903649020(11)241007(17)270831(10)4239015
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 06/04/2025

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: 4239015
• 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: 05/02/2025
• Supplement Date Received by Manufacturer: 06/04/2025
• Initial Report FDA Received Date: 05/30/2025
• Supplement Report FDA Received Date: 07/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/07/2024
• 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