MAUDE Adverse Event Report: BECTON, DICKINSON & CO., (BD) BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET; SEE H.10

Catalog Number 367344

Device Problem Leak/Splash (1354)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/26/2024

Event Type  malfunction  

Event Description

Report 8 of 8 it was reported that while using bd vacutainer® push button blood collection set, the blood stop flowing, and clogged causing back flow into the needle.This caused leakage at the luer-lock.No report of adverse or injury to the patient or the healthcare worker.

Manufacturer Narrative

D2: common device name: blood specimen collection device; intravascular administration set d.2.Medical device type: one additional code applies jka g5: pma/510(k)#: one additional code applies; k220212 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 Description

Report 8 of 8 it was reported that while using bd vacutainer® push button blood collection set, the blood stop flowing, and clogged causing back flow into the needle.This caused leakage at the luer-lock.No report of adverse or injury to the patient or the healthcare worker.

Manufacturer Narrative

The following fields have been updated with corrected and/or additional information.D10: device available for evaluation: yes d10: returned to manufacturer on: (b)(6) 2024 h.6.Investigation summary: material #: (b)(4) lot/batch #: (b)(4) bd received 25 samples and 1 photo for investigation.The photo was reviewed, and it shows the product unit label, confirming the lot number.Additionally, the customer samples were evaluated by functional draw testing and the indicated failure mode for leakage with the incident lot was not observed as all product specifications were met.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 is unable to be confirmed for the indicated failure mode leakage.Bd was not able to identify a root cause for the indicated failure mode.H3 other text : see h.10.

• Brand Name: BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET
• Type of Device: SEE H.10
• 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: 18956488
• MDR Text Key: 338554440
• Report Number: 1024879-2024-00253
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 50382903673440
• UDI-Public: (01)50382903673440
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K030573
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 367344
• Device Lot Number: 3317455
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/26/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/13/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1