MAUDE Adverse Event Report: BECTON, DICKINSON & CO., (BD) BD VACUTAINER® ULTRATOUCH¿ PUSH BUTTON BLOOD COLLECTION SET; SEE H11

Catalog Number	367363
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/27/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D2: common device name: blood specimen collection device; intravascular administration set d.2.Medical device type: one additional code applies;(b)(6).E1: initial reporter facility name: (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® ultratouch¿ push button blood collection set, blood leaked from the connector to the hub for 2 devices.No patient impact or user reported.
Event or Problem Description
It was reported that while using bd vacutainer® ultratouch¿ push button blood collection set, blood leaked from the connector to the hub for 2 devices.No patient impact or user reported.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d9: device available for evaluation: yes.H.3 device eval by manufacturer? yes.D9: returned to manufacturer on: 03-jul-2024.Investigation summary: bd received 5 samples (1 used and 4 unused) and 1 photo for investigation.The photo was reviewed and the indicated failure mode for leakage was observed.Additionally, 1 customer used sample was evaluated by visual examination and the issue of leakage was observed.Also, the 4 unused customer samples were subjected to a draw test to assess functionality of the device, and the issue of leakage was not found.Additionally, 30 retain samples were subjected to sleeve function testing using 10 tubes per needle to assess functionality of the device and no sign of damage or leakage observed.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 during use.Bd determined that the root cause of the indicated failure mode was attributed to the luers not being put onto the tubing properly which was corrected by adjusting the luer end of the tubing.There was also a broken depth probe which was the replaced and calibrated to reject any defective material.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® ULTRATOUCH¿ PUSH BUTTON BLOOD COLLECTION SET
• Common Device Name: SEE H11
• 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: 19610316
• Report Number: 1024879-2024-00563
• Device Sequence Number: 15574708
• Product Code: FPA
• UDI-Device Identifier: 00382903673636
• UDI-Public: (01)00382903673636
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K212724
• 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): 09/12/2024

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: 09/30/2025
• Device Catalogue Number: 367363
• Device Lot Number: 3262931
• 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: 05/27/2024
• Supplement Date Received by Manufacturer: 09/12/2024
• Initial Report FDA Received Date: 06/25/2024
• Supplement Report FDA Received Date: 09/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/19/2023
• 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