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

Catalog Number	368654
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Codes	Needle Stick/Puncture (2462); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/26/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported prior to usingbd vacutainer® safety-lok¿ blood collection set with pre-attached holder, the needle cap was missing and the needle point pierced through the packaging leading to a needlestick.No adverse impact was reported regarding the patient or user.
Additional Manufacturer Narrative
Investigation summary: bd received two photos for investigation.The photos show a sealed device with the cannula pushing through the packaging.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 been confirmed for the indicated failure modes: missing cap and needle stick through packaging.No definitive root cause could be established for the reported defect.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 WITH PRE-ATTACHED HOLDER
• Common Device Name: TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION
• Manufacturer (Section D): BECTON DICKINSON & CO (FRANKLIN LAKES); 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BECTON, DICKINSON & CO., (BD); 1575 airport road; sumter SC 29153
• Manufacturer Contact: anand singh ; 1 becton drive; franklin lakes, NJ 07417 ; 2018475186
• MDR Report Key: 24718877
• Report Number: 1024879-2026-00433
• Device Sequence Number: 6121884
• Product Code: JKA
• UDI-Device Identifier: 30382903686545
• UDI-Public: (01)30382903686545(17)270731(10)5231318
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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
• Report Date (Section B): 03/27/2026

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: 368654
• Device Lot Number: 5231318
• 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: 02/26/2026
• Initial Report FDA Received Date: 03/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/05/2025
• 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