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

Catalog Number	368688
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/19/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported when using the bd vacutainer® ultratouch¿ push button blood collection set with pah there was damage to the tubing, resulting in leakage in 6 devices.No adverse impact was reported regarding the patient or user.
Additional Manufacturer Narrative
There were multiple medical device types reported to be involved.The information for the additional device type is as follows: jka.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
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: 07-oct-2025.Investigation summary: bd received one photo and 13 samples for investigation.The customer-provided photo displays several devices with a bent iv cannula and one device with the cannula retracted into the sample, but there is no evidence of tubing damage.The 13 returned samples underwent visual inspection for preactivation of the iv cannula; out of these, eight samples failed as the iv cannula was retracted into the sample.Additionally, the samples were visually inspected for bent iv cannula, with five samples failing due to a bent cannula.All 13 samples passed visual inspection for holes in the tubing, as no evidence of damage or holes was observed.Furthermore, 100 retained samples were visually inspected for preactivation of the iv cannula, and all samples passed, exhibiting an iv cannula that had not yet been retracted.Another visual inspection for bent iv cannula was performed on 100 retained samples, and all samples passed with no evidence of bent cannula.In addition, 30 retained samples underwent functional tests to assess device functionality, and all samples passed, showing no signs of damage, leakage, or holes in the tubing.Based on a review of the device history record for the incident lot, all product specifications and requirements for lot release were met.This complaint has not been confirmed for the indicated failure mode: damaged.This complaint has been confirmed for the indicated failure modes: bent and preactivation.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 the identification of emerging trends.
Event or Problem Description
It was reported when using the bd vacutainer® ultratouch¿ push button blood collection set with pah there was damage to the tubing, resulting in leakage in 6 devices.No adverse impact was reported regarding the patient or user.

• Brand Name: BD VACUTAINER® ULTRATOUCH¿ PUSH BUTTON BLOOD COLLECTION SET WITH PAH
• Common Device Name: BLOOD COLLECTION SET, INVASIVE
• 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: anand singh ; 1 becton drive; franklin lakes, NJ 07417 ; 2018475186
• MDR Report Key: 23310817
• Report Number: 1024879-2025-01563
• Device Sequence Number: 4851839
• Product Code: FPA
• UDI-Device Identifier: 00382903686889
• UDI-Public: (01)00382903686889(10)432607
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• 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): 02/26/2026

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 Catalogue Number: 368688
• Device Lot Number: 4323607
• 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: 09/18/2025
• Supplement Date Received by Manufacturer: 02/26/2026
• Initial Report FDA Received Date: 10/16/2025
• Supplement Report FDA Received Date: 03/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/18/2024
• 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