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	368654
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/05/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H.3.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 while using bd vacutainer® safety-lok¿ blood collection set with pre-attached holder that blood is gushing and leaking out from the product wings.This occurred in 10 tubes and no patient impact reported.
Additional Manufacturer Narrative
Investigation summary : bd had received 2 customer photos for review and analysis.One of the customer photos shows a device with blood leakage near the cannula/wing and inside of the safety shield.However, the location of leakage could not be identified through the picture.Therefore, this complaint can be confirmed based on the customer photo provided.Bd is able to confirm the customer¿s reported failure mode of leakage during to injection/blood/urine collection based on customer photo analysis.Additionally, 30 retain samples were subjected to a sleeve function test to assess functionality of the device.All samples passed testing exhibiting no signs of damage or leakage during use.Therefore, this complaint cannot be confirmed based on the retain sample draw testing results.Bd is unable to confirm the customer¿s reported failure mode of leakage during to injection/blood/urine collection based on retain sample testing analysis.The device history record was reviewed with no issues being identified.There were no related quality notifications.All process and final inspections comply with specification requirements.This complaint is able to be confirmed for the indicated failure mode leakage.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.Information will be captured on trend reports and monitored.Our business team regularly reviews the collected data for identification of emerging trends.
Event or Problem Description
It was reported that while using bd vacutainer® safety-lok¿ blood collection set with pre-attached holder that blood is gushing and leaking out from the product wings.This occurred in 10 tubes and no patient impact reported.

• 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: 19010582
• Report Number: 1024879-2024-00287
• Device Sequence Number: 14405222
• Product Code: JKA
• UDI-Device Identifier: 00382903686544
• UDI-Public: (01)00382903686544
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/06/2024

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: 04/30/2025
• Device Catalogue Number: 368654
• Device Lot Number: 3110764
• 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: 03/05/2024
• Supplement Date Received by Manufacturer: 08/06/2024
• Initial Report FDA Received Date: 04/01/2024
• Supplement Report FDA Received Date: 08/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/22/2023
• 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