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

Catalog Number	367336
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/12/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Patient 7 of 10: it was reported while using bd vacutainer® push button blood collection set, 1 device was blocked during collection and patient had to be redrawn.There was no other health impact or consequences reported.
Additional Manufacturer Narrative
B3: date of event is unknown.The date received by manufacturer has been used for this field.D2b.There were multiple medical device types reported to be involved.The information for the additional device type is as follows: jka.D3.Common device name: tubes, vials, systems, serum separators, blood collection.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
Investigation summary bd received a photo for investigation, which shows an unopened blister pack.No visual evidence of the reported defect could be determined from the photo.Additionally, ten retained samples were tested, with each sample used to draw six tubes, resulting in a total of 60 tubes.All tubes filled as expected, and no evidence of clogged cannulas was observed during functional tests.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: clog.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
Patient 7 of 10: it was reported while using bd vacutainer® push button blood collection set, 1 device was blocked during collection and patient had to be redrawn.There was no other health impact or consequences reported.

• Brand Name: BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET
• 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 AND COMPANY (BD); belliver way; belliver industrial estate; plymouth ; UK
• Manufacturer Contact: anand singh ; 1 becton drive; franklin lakes, NJ 07417 ; 2018475186
• MDR Report Key: 23751819
• Report Number: 9617032-2025-02173
• Device Sequence Number: 20297196
• Product Code: FPA
• UDI-Device Identifier: 00382903673360
• UDI-Public: (01)00382903673360(17)270731(10)5204764
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K220212
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/23/2025

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: 367336
• Device Lot Number: 5204764
• 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: 11/12/2025
• Supplement Date Received by Manufacturer: 12/23/2025
• Initial Report FDA Received Date: 12/08/2025
• Supplement Report FDA Received Date: 01/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/23/2025
• 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