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

Catalog Number	367363
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/15/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that while using bd vacutainer® ultratouch¿ push button blood collection set, the customer noticed the information on the package labels are misprinted.There was no health impact or consequence reported.
Additional Manufacturer Narrative
D.2b medical device type: one additional code applies; 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
He 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: 04-sep-2025.Investigation summary: bd received 4 shelf cartons and 2 photos for investigation.The photos were reviewed and the indicated failure mode for missing label was observed.The customer photos show a shelf carton that is missing a label additionally, the customer samples along with 2 retention shelf cartons were visually evaluated all shelf cartons inspected (returns and retains) were missing a label.A review of the device history record indicated a quality notification was raised for this issue.However, product was dispositioned according to procedure and lot passed all in-process and final quality checks for lot release.This complaint has been confirmed for the indicated failure mode missing label.Bd was not able to identify a root cause for the indicated failure mode.Based on the low defect rate for the batch in question, no actions are planned at this time.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, the customer noticed the information on the package labels are misprinted.There was no health impact or consequence reported.
Event or Problem Description
It was reported that while using bd vacutainer® ultratouch¿ push button blood collection set, the customer noticed the information on the package labels are misprinted.There was no health impact or consequence reported.
Additional Manufacturer Narrative
Investigation summary: bd received one photo for investigation.The customer photo shows a shelf carton with a missing label.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: incorrect/missing label information.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.Our business team regularly reviews the collected data for the identification of emerging trends.

• Brand Name: BD VACUTAINER® ULTRATOUCH¿ PUSH BUTTON BLOOD COLLECTION SET
• Common Device Name: INTRAVASCULAR ADMINISTRATION SET
• 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: matt j. connor ; 7 loveton circle; sparks, MD 21152 ; 4103164000
• MDR Report Key: 22738553
• Report Number: 1024879-2025-01080
• Device Sequence Number: 17941641
• Product Code: FPA
• UDI-Device Identifier: 00382903673636
• UDI-Public: (01)00382903673636(11)241209(17)261130(10)4344496
• Combination Product (Y/N): N
• Initial Reporter Country: SA
• 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,Followup
• Report Date (Section B): 03/09/2026

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: 367363
• Device Lot Number: 4344496
• 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: 07/15/2025
• Supplement Date Received by Manufacturer: 02/27/2026; 03/09/2026
• Initial Report FDA Received Date: 08/07/2025
• Supplement Report FDA Received Date: 03/02/2026; 03/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/09/2024
• 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