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	368654
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/07/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There were multiple lot numbers reported to be involved.The information for each additional lot number is as follows: d4.Medical device lot#:4190004.D4.Medical device expiration date: 30-jun-2026.H4.Device manufacture date: 02-aug-2024.Unique identifier (udi) #: (b)(4).D4.Medical device lot#: 4193133.D4.Medical device expiration date: 30-jun-2026.H4.Device manufacture date: 01-aug-2024.Unique identifier (udi) #:(b)(4).Date of event is unknown.The date received by manufacturer has been used for this field.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 prior to using bd vacutainer® safety-lok¿ blood collection set with pre-attached holder, there were particles and foreign bodies observed in 4 units of batch number 4190004, and 1 unit for each batch 4193133 and 4190002.No patient impact reported.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d9: device available for evaluation: yes.H.3 device eval by manufacturer? yes.D9: returned to manufacturer on: 15-nov-2024.Investigation summary: bd received one sample and four photos for investigation related to lot 4193133.The photos show several devices with foreign matter on or in the blister pack or seal.The returned sample passed testing with no foreign matter found on or in the device packaging.Additionally, 100 retained samples were inspected and all passed testing with no foreign matter found.For lot 4190004, bd received four samples for investigation.Upon inspection, two of the four returned samples failed testing due to foreign matter in the device packaging or seal.Another 100 retained samples were inspected and all passed testing with no foreign matter found.For lot 4190002, bd received one sample for investigation.The returned sample passed testing with no foreign matter found on or in the device packaging.Additionally, 100 retained samples were inspected and all passed testing with no foreign matter found.Based on a review of the device history record for the incident lots, all product specifications and requirements for lot release were met.This complaint has been confirmed for the lots 4190002, 4190004 and 4193133, for the indicated failure mode: foreign matter - unknown.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
It was reported prior to using bd vacutainer® safety-lok¿ blood collection set with pre-attached holder, there were particles and foreign bodies observed in 4 units of batch number 4190004, and 1 unit for each batch 4193133 and 4190002.No patient impact reported.

• 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: jo doyka ; 7 loveton circle; sparks, MD 21152 ; 4103164000
• MDR Report Key: 20613076
• Report Number: 1024879-2024-00992
• Device Sequence Number: 15292028
• Product Code: JKA
• UDI-Device Identifier: 00382903686544
• UDI-Public: (01)00382903686544(11)240812(17)260630(10)4190002
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 03/06/2025

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: Other
• Device Expiration Date: 06/30/2026
• Device Catalogue Number: 368654
• Device Lot Number: 4190002
• 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: 10/07/2024
• Supplement Date Received by Manufacturer: 03/06/2025
• Initial Report FDA Received Date: 11/05/2024
• Supplement Report FDA Received Date: 04/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/12/2024
• 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