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	08/07/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D.2b medical device type: one additional code applies; jka.D.2a.Common device name: blood specimen collection device; intravascular administration set.Investigation summary: bd received eight (8) samples for investigation.The samples were evaluated by visual examination and the indicated failure mode for pre-activation with the incident lot was not observed.Also, 7 of the 8 customer samples were subjected to sleeve function and retraction lockout testing to assess functionality of the device and no leakage or separation/breakage were observed during use.However, the eighth sample was not able to be tested for functionality as the iv cannula of the device was bent prior to use.Additionally, 100 retention samples from bd inventory were evaluated by visual examination for bent iv cannula and pre-activation and no issues were found, and 30 retention samples were evaluated by functional testing and the issue of leakage and separation/breakage during use were not 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 bent needle based on returned sample analysis and unconfirmed for leakage, pre-activation and separation during use.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.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® ultratouch¿ push button blood collection set, blood leaked from body of the device 22 times, and the needle separated from the device while still in patient arm on (1) device.No patient or user impact reported.

• 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: 20156095
• Report Number: 1024879-2024-00791
• Device Sequence Number: 14512024
• Product Code: FPA
• UDI-Device Identifier: 30382903673637
• UDI-Public: (01)30382903673637
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• 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,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/09/2024

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: 02/28/2026
• Device Catalogue Number: 367363
• Device Lot Number: 4057091
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/15/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/07/2024
• Initial Report FDA Received Date: 09/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/26/2024
• 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