MAUDE Adverse Event Report: BECTON, DICKINSON & CO., (BD) BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET WITH PRE-ATTACHED HOLDER; BLOOD SPECIMEN COLLECTION DEVICE

Catalog Number	368653
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	03/13/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1.Initial reporter phone #: (b)(6).H.3.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 prior to using bd vacutainer® safety-lok¿ blood collection set with pre-attached holder, there is dirt in the unopened packaging.No patient impact reported.
Event or Problem Description
It was reported that prior to using bd vacutainer® safety-lok¿ blood collection set with pre-attached holder, there is dirt in the unopened packaging.No patient impact reported.
Additional Manufacturer Narrative
Investigation summary: bd had not received samples, but eight (8) photos were provided for investigation.The 8 photos show a device with darkened spots on the light blue wing.Therefore, this complaint can be confirmed based on the customer photos provided.Additionally, 100 retain samples were visually inspected for foreign matter on the wing.All samples passed testing exhibiting no foreign matter.Based on a review of the device history record for the incident lot, all product specifications and requirements for lot release were met.There were no related quality issues during manufacturing of the product.This complaint has been confirmed for the indicated failure mode foreign matter.Bd was not able to identify a root cause for the indicated failure mode.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.

• Brand Name: BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET WITH PRE-ATTACHED HOLDER
• Common Device Name: BLOOD SPECIMEN COLLECTION DEVICE
• 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: 19070410
• Report Number: 1024879-2024-00323
• Device Sequence Number: 15178586
• Product Code: JKA
• UDI-Device Identifier: 00382903686537
• UDI-Public: (01)00382903686537
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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): 07/22/2024

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: 02/28/2025
• Device Catalogue Number: 368653
• Device Lot Number: 3061812
• 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: 03/13/2024
• Supplement Date Received by Manufacturer: 07/21/2024
• Initial Report FDA Received Date: 04/09/2024
• Supplement Report FDA Received Date: 07/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/12/2023
• 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