MAUDE Adverse Event Report: Becton Dickinson & CO (Franklin Lakes) BD Vacutainer® One Use Holder; Tubes, vials, systems, serum separators, blood collection

Catalog Number	364815
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/17/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported while using bd vacutainer® one use holder, an unspecified number of devices separate from the wingset when multiple tubes are being collected.There was no health impact or consequences reported.
Additional Manufacturer Narrative
Investigation summary: bd had not received samples or photos for evaluation.There has been no sample movement for 30 calendar days.The investigation was concluded based on the information available to date.If samples become available, the complaint may be reopened.Therefore, retention samples from bd inventory were visually inspected with no defects 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.While bd was unable to confirm this complaint for the indicated failure mode separates, bd has initiated further root cause investigation relating to the issue of separates through corrective and preventive actions.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.

• Brand Name: BD Vacutainer® One Use Holder
• Common Device Name: Tubes, vials, systems, serum separators, blood collection
• Manufacturer (Section D): Becton Dickinson & CO (Franklin Lakes); 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BECTON DICKINSON, S.A.; cr mequinenza; s/n; fraga, huesca 22520 ; SP 22520
• Manufacturer Contact: anand singh ; 1 becton drive; franklin lakes, NJ 07417 ; +1(201)847-5186
• MDR Report Key: 50780214
• Report Number: 3002682307-2026-00188
• Device Sequence Number: 10754353
• Product Code: JKA
• UDI-Device Identifier: 30382903648154
• UDI-Public: (01)30382903648154(11)260417(10)6107482
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K242320
• 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
• Report Date (Section B): 08/20/2026

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: 364815
• Device Lot Number: 6107482
• 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: 08/18/2026
• Initial Report FDA Received Date: 09/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/17/2026
• 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