MAUDE Adverse Event Report: BECTON DICKINSON BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET; BLOOD SPECIMEN COLLECTION DEVICE

Catalog Number	367281
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/15/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturing location for this product is nipro.This site is an oem manufacturing site.Therefore, bd corporate headquarters in (b)(4), nj has been listed in sections and the franklin lakes fda registration number has been used for the manufacture report number 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 the bd vacutainer® safety-lok¿ blood collection set, there was blood leakage from the end with the sheath after the tube was detached.The blood dripped on the patients arm and clothing, but there was no report of patient impact.The customer reported this occurred at least 10 times.
Additional Manufacturer Narrative
H.6 investigation summary bd had not received samples, but two (2) photos were provided for investigation.The photos were reviewed and the indicated failure mode for leakage was observed.A reproduction test was conducted on a retained sample of the lot concerned.The retained sample was inserted in a model blood circuit filled with colored water, and then a bd blood tube was inserted.When the retained wingset sample was removed from the blood circuit with the blood tube still inserted in the luer adapter, the colored water back flowed and leaked from the tip of the needle due to the change of the pressure.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 leakage based on the photo.Bd determined that the root cause of the indicated failure mode was attributed to pressure change caused by removing the wingset from the patient with the blood tube still inserted in the luer adapter.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.
Event or Problem Description
It was reported that while using the bd vacutainer® safety-lok¿ blood collection set, there was blood leakage from the end with the sheath after the tube was detached.The blood dripped on the patients arm and clothing, but there was no report of patient impact.The customer reported this occurred at least 10 times.

• Brand Name: BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET
• Common Device Name: BLOOD SPECIMEN COLLECTION DEVICE
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer Contact: jo doyka ; 7 loveton circle; sparks, MD 21152 ; 4103164000
• MDR Report Key: 19319462
• Report Number: 2243072-2024-00628
• Device Sequence Number: 18054488
• Product Code: JKA
• UDI-Device Identifier: 00382903672813
• UDI-Public: (01)00382903672813
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 05/17/2024

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: Health Professional
• Device Expiration Date: 05/31/2026
• Device Catalogue Number: 367281
• Device Lot Number: 23E1611
• 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: 04/15/2024
• Supplement Date Received by Manufacturer: 06/25/2024
• Initial Report FDA Received Date: 05/15/2024
• Supplement Report FDA Received Date: 07/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/26/2023
• 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