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	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/02/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported while using bd vacutainer® push button blood collection set, blood leaked from the hub of the device in 75 devices.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.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 while using bd vacutainer® push button blood collection set, blood leaked from the hub of the device in 75 devices.No adverse impact was reported regarding the patient or user.
Additional Manufacturer Narrative
The 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: 13-mar-2026.Investigation summary: bd received 9 samples(1 used and 8 unused) and 3 photos for investigation.The photos were reviewed and show a device with blood leakage in the barrel and on the wings.Additionally, the 1 used customer sample was subjected to visual inspection for leakage.The sample failed testing as there was leakage present.However, the specific location of the leakage could not be determined since the sample was used.Furthermore, the 8 unused customer samples were subjected to sleeve function testing using 10 tubes per needle.All the samples passed as there was no evidence of damage to the device or leakage during use.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.Bd is able to confirm the customer's reported failure mode of leakage during to injection/blood/urine collection based on the used customer sample testing results and he photos provided.Bd was not able to identify a root cause for the indicated failure mode.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® 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: 24747741
• Report Number: 1024879-2026-00452
• Device Sequence Number: 21187819
• Product Code: FPA
• UDI-Device Identifier: 30382903673446
• UDI-Public: (01)30382903673446(11)260109(17)271231(10)6009540
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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,Followup
• Report Date (Section B): 04/29/2026

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: 6009540
• 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: 03/03/2026
• Supplement Date Received by Manufacturer: 04/29/2026
• Initial Report FDA Received Date: 03/31/2026
• Supplement Report FDA Received Date: 05/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/09/2026
• 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