MAUDE Adverse Event Report: BECTON DICKINSON VACUTAINER SAFETY-LOK; BLOOD SPECIMEN COLLECTION DEVICE

Catalog Number	367287
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/28/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported while using ten (10) unspecified bd vacutainer® tube, the customer noticed blood leakage at the end of the blood collection tubes.No adverse impact was reported regarding the patient or user.
Additional Manufacturer Narrative
Unknown manufacturer: a catalog and lot number could not be confirmed for this incident and without this information we are unable to determine where the device was manufactured.Therefore, bd corporate headquarters in franklin lakes, nj has been listed in sections d.3.And g.1.And the franklin lakes fda registration number has been used for the manufacture report number.D4.Medical device expiration date: unknown.D4.Unique identifier (udi) #: unknown.H4.Device manufacture date: unknown.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Additional Manufacturer Narrative
The following fields were updated due to additional information: b.5 describe event or problem: it was reported while using ten (10) vacutainer safety-lok, the customer noticed blood leakage at the end of the blood collection tubes.No adverse impact was reported regarding the patient or user.D.1 medical device brand name: vacutainer safety-lok.D.4.Medical device catalog # 367287.D4.Medical device lot #: 24g03a2.D4.Medical device expiration date: 30-jun-2026.H4.Device manufacture date: 27-aug-2024.D.4 udi#: ((b)(4).Investigation summary: bd had not received samples or photos of the defects for investigation.Therefore, 50 retention samples from bd inventory were evaluated by visual examination and nothing abnormal was found from the rubber sleeves.Also, functional testing was conducted on 8 retained samples using bd tubes and nothing abnormal was observed as no rubber sleeve retracting defects or side-piercing defects occurred during the test, all samples met specifications.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 of sleeve leakage based on retains testing.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
It was reported while using ten (10) vacutainer safety-lok, the customer noticed blood leakage at the end of the blood collection tubes.No adverse impact was reported regarding the patient or user.

• Brand Name: VACUTAINER SAFETY-LOK
• Common Device Name: BLOOD SPECIMEN COLLECTION DEVICE
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer Contact: matt j. connor ; 7 loveton circle; sparks, MD 21152 ; 4103164000
• MDR Report Key: 22342008
• Report Number: 2243072-2025-00801
• Device Sequence Number: 13010452
• Product Code: JKA
• UDI-Device Identifier: 30382903672876
• UDI-Public: (01)30382903672876(17)260630(10)24G03A2
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: UNKNOWN
• 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): 07/22/2025

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 Expiration Date: 06/30/2026
• Device Catalogue Number: 367287
• Device Lot Number: 24G03A2
• 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: 05/28/2025
• Supplement Date Received by Manufacturer: 08/13/2025
• Initial Report FDA Received Date: 06/26/2025
• Supplement Report FDA Received Date: 09/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/27/2024
• 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