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

Catalog Number	368652
Medical Device Problem Code	Short Fill (1575)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/03/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1: initial reporter city: (b)(6) 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 customer noticed the blood is mixed with air in areas where blood does not normally enter on one (1) device.No patient impact reported.
Event or Problem Description
It was reported that while using bd vacutainer® safety-lok¿ blood collection set pre-attached holder, the customer noticed the blood is mixed with air in areas where blood does not normally enter on one (1) device.No patient impact reported.
Additional Manufacturer Narrative
Investigation summary bd had not received samples, but one (1) photo was provided for investigation.The photo was reviewed and the indicated failure mode for air bubble was observed.Additionally, 30 retain samples were subjected to a draw test to assess air bubbles during use and all the samples passed with no evidence of air bubbles or air leakage during draw.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 of air bubbles based on the photo analysis.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 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: 20359450
• Report Number: 1024879-2024-00888
• Device Sequence Number: 7199328
• Product Code: JKA
• UDI-Device Identifier: 30382903686521
• UDI-Public: (01)30382903686521(11)231026(17)250731(10)3202235
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 11/18/2024

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: 07/31/2025
• Device Catalogue Number: 368652
• Device Lot Number: 3202235
• 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: 09/04/2024
• Supplement Date Received by Manufacturer: 11/18/2024
• Initial Report FDA Received Date: 10/03/2024
• Supplement Report FDA Received Date: 11/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/26/2023
• 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