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	12/26/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 while using bd vacutainer® safety-lok¿ blood collection set with pre-attached holder, the blood was leaking out of the safety cap of the wingset.No patient impact reported.
Additional Manufacturer Narrative
H.6.Investigation summary: bd received four (4) samples and two (2) photos for investigation.The photos were reviewed and the indicated failure mode for leakage was observed.Additionally, the customer 4 samples along with 30 retain samples were subjected to a draw test to assess functionality of the device and the issue of leakage during use was not observed.A review of the device history record indicated a quality notification was raised for this issue.However, lot passed all in-process and final quality checks for lot release.This complaint has been confirmed for the indicated failure mode of leakage during use.Bd determined that the root cause of the indicated failure mode of leakage was attributed to work piece holder and windhead interference causing cut tubing.The corrective actions included replacing the homing sensor for the wind head and adjusting the home offset to align the slot in the windhead to the nest.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.The following fields have been updated with additional/corrected information: d.9.Device available for eval: yes.D.9.Returned to manufacturer on: 19-feb-2024.
Event or Problem Description
It was reported that while using bd vacutainer® safety-lok¿ blood collection set with pre-attached holder, the blood was leaking out of the safety cap of the wingset.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: 18527176
• Report Number: 1024879-2024-00008
• Device Sequence Number: 20758025
• Product Code: JKA
• UDI-Device Identifier: 00382903686544
• UDI-Public: (01)00382903686544
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K991088
• 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): 05/31/2024

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: 368654
• Device Lot Number: 3205448
• 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: 12/26/2023
• Supplement Date Received by Manufacturer: 05/31/2024
• Initial Report FDA Received Date: 01/17/2024
• Supplement Report FDA Received Date: 06/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/25/2023
• 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