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

Catalog Number	368687
Medical Device Problem Code	Unsealed Device Packaging (1444)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/16/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3: date of event is unknown.The date received by manufacturer has been used for this field.D2a.There were multiple medical device types reported to be involved.The information for the additional device type is as follows: jka d2b.Common device name: tubes, vials, systems, serum separators, blood collection a device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that upon receipt of the bd vacutainer® ultratouch¿ push button blood collection set with pah, the customer observed that 100 units of the collection set packages were not sealed.No patient or user impact was reported.
Additional Manufacturer Narrative
Investigation summary: bd received one video and one photo for investigation.The video shows samples that are warped in the shelf cartons.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 - sterility in question.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 that upon receipt of the bd vacutainer® ultratouch¿ push button blood collection set with pah, the customer observed that 100 units of the collection set packages were not sealed.No patient or user impact was reported.

• Brand Name: BD VACUTAINER® ULTRATOUCH¿ PUSH BUTTON BLOOD COLLECTION SET WITH PAH
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BECTON DICKINSON & CO (FRANKLIN LAKES); 1 becton drive; franklin lakes NJ 07417
• 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: 24053715
• Report Number: 1024879-2025-02419
• Device Sequence Number: 13135240
• Product Code: FPA
• UDI-Device Identifier: 00382903686872
• UDI-Public: (01)00382903686872(11)250724(17)270630(10)5205214
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• 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: 368687
• Device Lot Number: 5205214
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/16/2025
• Supplement Date Received by Manufacturer: 02/26/2026
• Initial Report FDA Received Date: 01/13/2026
• Supplement Report FDA Received Date: 03/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/24/2025
• 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