MAUDE Adverse Event Report: BECTON, DICKINSON & CO., (BD) BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET PRE-ATTACHED HOLDER; TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION

Catalog Number	368653
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/16/2025
Type of Reportable Event	Malfunction
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 that while using ten bd vacutainer® safety-lok¿ blood collection set pre-attached holder, the customer noticed leakage from the connection.There was no health impact or consequence reported.
Additional Manufacturer Narrative
Investigation summary.Two photos were received for review and analysis.One photo shows a device package.One photo shows a previously used device.However, we are unable to determine leakage point based on photo analysis.Bd is unable to confirm this complaint based on photo sample analysis.30 retain samples were visually inspected and tested for sleeve functionality.All samples passed testing.Therefore, this complaint cannot be confirmed based on retain sample testing results.The device history record was reviewed with no issues being identified.There were no related quality notifications.All process and final inspections comply with specification requirements.Based on a review of batch records and investigation results, no root cause from manufacturing was identified as a contributor.Based on an evaluation of severity and frequency it was determined that no corrective action is required at this time.Complaints received about 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 identification of emerging trends.
Event or Problem Description
It was reported that while using ten bd vacutainer® safety-lok¿ blood collection set pre-attached holder, the customer noticed leakage from the connection.There was no health impact or consequence reported.

• Brand Name: BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET PRE-ATTACHED HOLDER
• Common Device Name: TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION
• Manufacturer (Section D): BECTON, DICKINSON & CO., (BD); 1575 airport road; sumter SC 29153
• Manufacturer (Section G): BECTON, DICKINSON & CO., (BD); 1575 airport road; sumter SC 29153
• Manufacturer Contact: matt j. connor ; 7 loveton circle; sparks, MD 21152 ; 4103164000
• MDR Report Key: 22772464
• Report Number: 1024879-2025-01086
• Device Sequence Number: 15775227
• Product Code: JKA
• UDI-Device Identifier: 00382903686537
• UDI-Public: (01)00382903686537(11)250428(17)270331(10)5099299
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K980414
• 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): 01/13/2026

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: 368653
• Device Lot Number: 5099299
• 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: 07/16/2025
• Supplement Date Received by Manufacturer: 01/13/2026
• Initial Report FDA Received Date: 08/11/2025
• Supplement Report FDA Received Date: 01/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/28/2025
• 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