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

Catalog Number	367287
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/09/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that when using the bd vacutainer® safety-lok¿ blood collection set, blood leakage was observed with one unit resulting in contamination of the nurse's gloves.No adverse impact was reported regarding the patient or user.
Additional Manufacturer Narrative
The manufacturing location for this product is nipro.This site is an oem manufacturing site.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.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 that when using the bd vacutainer® safety-lok¿ blood collection set, blood leakage was observed with an unspecified number of units.No adverse impact was reported regarding the patie.
Additional Manufacturer Narrative
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 tube holders and nothing abnormal was observed as no rubber sleeve retracting defects, side-piercing defects or leakage during the test.Furthermore, as simulation, a luer adapter was inserted to a bd blood collection tube without being attached to a bd single use holder, and the rubber sleeve root was displaced onto the thread of the needle hub, causing the needle tip was exposed from near the rubber sleeve tip.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.Bd determined that the root cause of the indicated failure mode was attributed to the luer adapter not attached to the holder before inserting the tube.This caused the rubber sleeve to be displaced onto the thread of the needle hub and the needle tip got exposed due to excessive insertion force.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.

• Brand Name: BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET
• 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: 22644490
• Report Number: 2243072-2025-00929
• Device Sequence Number: 8718729
• 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: 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 08/26/2025

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: Health Professional
• 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: 07/09/2025
• Supplement Date Received by Manufacturer: 08/26/2025
• Initial Report FDA Received Date: 07/29/2025
• Supplement Report FDA Received Date: 09/23/2025
• 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