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

Catalog Number	367344
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/10/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported while using bd vacutainer® push button blood collection set, after pressing the retraction button, the needle only retracted halfway.Customer had to press the retraction button again for full needle retraction.No adverse impact was reported regarding the patient or user.
Additional Manufacturer Narrative
There were multiple medical device types reported to be involved.The information for the additional device type is as follows.D.2.B medical device type: jka.D.2.A common device name: tubes, vials, systems, serum separators, blood collection.D.4.Medical device expiration date: unknown.H.4.Device manufacture date: unknown.The lot number was not reported; however, a potential lot number was provided.The information for that number is as follows: d4.Medical device lot#: 5330825.D4.Medical device expiration date: 30-11-2027.H4.Device manufacture date: 01-12-2025.Investigation summary: bd received a photo for investigation, which shows a device with the cannula partially retracted after use.Retained samples could not be tested as the batch number is unknown.The device history records could not be reviewed as the lot number is unknown.This complaint has been confirmed for the indicated failure mode: retraction issue.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.

• 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 & CO., (BD); 1575 airport road; sumter SC 29153
• Manufacturer Contact: anand singh ; 1 becton drive; franklin lakes, NJ 07417 ; 2018475186
• MDR Report Key: 24817972
• Report Number: 1024879-2026-00519
• Device Sequence Number: 13183284
• Product Code: FPA
• UDI-Device Identifier: 30382903673446
• UDI-Public: (01)30382903673446
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• 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,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/16/2026

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: 367344
• Device Lot Number: UNKNOWN
• 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: 03/11/2026
• Initial Report FDA Received Date: 04/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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