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

Catalog Number	368652
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/30/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3: date of event is unknown.The date received by manufacturer has been used for this field.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 before using one (1) carton of the bd vacutainer® safety-lok¿ blood collection set pre-attached holder, the barcode printed on the packaging corresponds to a different product.No adverse impact was reported regarding the patient or user.
Additional Manufacturer Narrative
Investigation summary: bd received two photos for investigation.One of the customer photos displays a shelf carton with a gtin that does not match the catalog number of the batch.A review of the device history record was completed.Product quality is evaluated during the manufacturing process with prescribed variable and attributes inspections.All inspections were in compliance with requirements.There were no related quality notifications.This complaint has been confirmed for the indicated failure mode: incorrect/missing label information.Based on a review of batch records, no root cause from manufacturing was identified as a contributor.Based on an evaluation of severity and frequency it was determined that no corrective actions are required.Complaints received for this device and reported condition will continue to be tracked and trended.Our business team regularly reviews the collected data for the identification of emerging trends.
Event or Problem Description
It was reported that before using one (1) carton of the bd vacutainer® safety-lok¿ blood collection set pre-attached holder, the barcode printed on the packaging corresponds to a different product.No adverse impact was reported regarding the patient or user.
Additional Manufacturer Narrative
The following investigation summary was updated due to corrected information: h.11 imdrf annex d grid (1: d03 - cause traced to manufacturing.Imdrf annex c grid (1) c16 - manufacturing process problem identified.Investigation summary: bd received 1 photo for investigation.The photo was reviewed and the indicated failure mode for incorrect label content was observed; it displayed a shelf carton with a gtin that does not match the catalog number of the batch.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 mode incorrect label content.During the manufacture of material 368652 batch # 5251729 the material number that was printed within the barcode (gtin) on the shelf carton was incorrectly printed as 368654, while the batch number and expiration date information of the shelf carton is correct.However, all information printed on the unit packages and case cartons were correct.Reinforcement training and process improvements were implemented to support ongoing control and documentation accuracy.A complaint history review did not reveal a trend for this issue.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.
Event or Problem Description
It was reported that before using one (1) carton of the bd vacutainer® safety-lok¿ blood collection set pre-attached holder, the barcode printed on the packaging corresponds to a different product.No adverse impact was reported regarding the patient or user.

• 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 (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: 24189685
• Report Number: 1024879-2026-00044
• Device Sequence Number: 21210777
• Product Code: JKA
• UDI-Device Identifier: 30382903686521
• UDI-Public: (01)30382903686521(17)270831(10)5251729
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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,Followup
• Report Date (Section B): 04/20/2026

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: 368652
• Device Lot Number: 5251729
• 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: 12/30/2025
• Supplement Date Received by Manufacturer: 03/26/2026; 04/28/2026
• Initial Report FDA Received Date: 01/27/2026
• Supplement Report FDA Received Date: 04/16/2026; 05/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/28/2025
• 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