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

Catalog Number	368689
Medical Device Problem Code	Unsealed Device Packaging (1444)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/19/2025
Type of Reportable Event	Malfunction
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.
Event or Problem Description
It was reported before using the bd vacutainer® ultratouch¿ push button blood collection set with pah there were 30 devices that were delivered with the packaging blisters open rending them non-sterile.No adverse impact was reported regarding the patient or user.
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: 06-oct-2025.Investigation summary: bd received 12 samples and 4 photos for investigation.The photos depict individual blister packs with warped or damaged packaging and an open seal.All 12 samples underwent visual inspection for open or damaged packaging, and each sample failed testing due to warped packaging that resulted in an open seal.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 been confirmed for the indicated failure mode: open package/seal.No definitive root cause could be established for the reported defect.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.Our business team regularly reviews the collected data for the identification of emerging trends.
Event or Problem Description
It was reported before using the bd vacutainer® ultratouch¿ push button blood collection set with pah there were 30 devices that were delivered with the packaging blisters open rending them non-sterile.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: 23311100
• Report Number: 1024879-2025-01570
• Device Sequence Number: 17596050
• Product Code: FPA
• UDI-Device Identifier: 00382903686896
• UDI-Public: (01)00382903686896(11)250619(17)270531(10)5170625
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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): 02/17/2026

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: 368689
• Device Lot Number: 5170625
• 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: 09/19/2025
• Supplement Date Received by Manufacturer: 02/17/2026
• Initial Report FDA Received Date: 10/16/2025
• Supplement Report FDA Received Date: 03/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/19/2025
• 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