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

Catalog Number	368653
Medical Device Problem Codes	Product Quality Problem (1506); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	06/20/2025
Type of Reportable Event	Serious Injury
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
Report 3 of 3 it was reported that while using one bd vacutainer® safety-lok¿ blood collection set pre-attached holder, the nurse obtained a needlestick injury when discarding the butterfly.There was no other health impact or consequence reported.
Additional Manufacturer Narrative
Investigation summary bd received samples for investigation, totaling 20 units.The samples were visually inspected for cracked safety shields, and all passed with no observed cracks or damage.All process and final inspections complied with specification requirements.Additionally, 100 retained samples underwent visual inspection for cracked safety shields, and another 100 retained samples were inspected for bent iv and np cannula; all retained samples passed testing.All 20 returned samples also passed functional tests for shield activation.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 mode: needle stick.Based on a review of batch records and investigation results, no root cause from manufacturing was identified as a contributor.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
Report 3 of 3.It was reported that while using one bd vacutainer® safety-lok¿ blood collection set pre-attached holder, the nurse obtained a needlestick injury when discarding the butterfly.There was no other health impact or consequence reported.

• Brand Name: VACUTAINER SAFETY-LOK
• 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: 22556290
• Report Number: 1024879-2025-01004
• Device Sequence Number: 21224128
• Product Code: JKA
• UDI-Device Identifier: 00382903686537
• UDI-Public: (01)00382903686537(10)5094122
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• 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,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/04/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Other
• Device Catalogue Number: 368653
• Device Lot Number: 5094122
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/23/2025
• Supplement Date Received by Manufacturer: 12/04/2025
• Initial Report FDA Received Date: 07/21/2025
• Supplement Report FDA Received Date: 12/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/24/2025
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown