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	368652
Medical Device Problem Code	Product Quality Problem (1506)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	06/13/2025
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
It was reported that while using bd vacutainer® safety-lok¿ blood collection set pre-attached holder, the nurse obtained dirty needlestick injury when a previously discarded blood collection set caught up in the plastic wings that are molded into the lid and the exposed needle was protruding from the container.First aid and medical follow-up steps were taken, including hiv, hep b, and hep c testing and referral to infectious diseases.Reported verbatim: it was reported that during a routine venipuncture, the rn disposed of the used blood collection set into a bd sharps collector, portable (ref 303205) container located in the participant¿s room.A previously discarded blood collection set bd safety-lok¿ blood collection set 368652 had been caught up in the plastic wings that are molded into the lid and the exposed needle was protruding from the container.Noting that the safety-lok had not been activated after completing a previous blood draw.As a result, the rn sustained a needlestick injury.
Event or Problem Description
It was reported that while using bd vacutainer® safety-lok¿ blood collection set pre-attached holder, the nurse obtained dirty needlestick injury when a previously discarded blood collection set caught up in the plastic wings that are molded into the lid and the exposed needle was protruding from the container.First aid and medical follow-up steps were taken, including hiv, hep b, and hep c testing and referral to infectious diseases.Reported verbatim: it was reported that during a routine venipuncture, the rn disposed of the used blood collection set into a bd sharps collector, portable (ref (b)(4) container located in the participant¿s room.A previously discarded blood collection set bd safety-lok¿ blood collection set 368652 had been caught up in the plastic wings that are molded into the lid and the exposed needle was protruding from the container.Noting that the safety-lok had not been activated after completing a previous blood draw.As a result, the rn sustained a needlestick injury.
Additional Manufacturer Narrative
Investigation summary bd received photos for investigation.The customer's photo provides an example of the ifu and a device in a sharps container; however, it does not show the reported defect.A total of 30 retained samples were visually inspected for sleeve functionality, and all samples passed testing.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: difficult/unable to operate.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.

• 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: 22557562
• Report Number: 1024879-2025-01006
• Device Sequence Number: 15877976
• Product Code: JKA
• UDI-Device Identifier: 00382903686520
• UDI-Public: (01)00382903686520(11)240109(17)251130(10)3310240
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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): 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?: Yes
• Operator of Device: Other
• Device Expiration Date: 11/30/2025
• Device Catalogue Number: 368652
• Device Lot Number: 3310240
• 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: 06/23/2025
• Supplement Date Received by Manufacturer: 12/04/2025
• Initial Report FDA Received Date: 07/21/2025
• Supplement Report FDA Received Date: 12/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/09/2024
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown