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

Catalog Number	367338
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Exposure to Body Fluids (1745)
Date of Event	02/26/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported while using bd vacutainer® push button blood collection set, the hub of one device was cracked resulting in sample leakage and recollection.Blood got onto the healthcare workers hands.There is no report of the level of ppe worn, post exposure testing or medical intervention.
Additional Manufacturer Narrative
D2a.There were multiple medical device types reported to be involved.The information for the additional device type is as follows: jka d2b.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.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d.9: device available for evaluation: yes.H.3 device eval by manufacturer? yes.D9: returned to manufacturer on: 31-mar-2026.Investigation summary: bd received three samples for investigation.Visual examination of the returned samples did not reveal any signs of a cracked female luer.These three samples were subjected to functional tests, and no leakage was observed.Additionally, visual examination of ten retained samples did not show any signs of a cracked female luer.The ten retained samples were also used for functional tests, and no leakage occurred.The device history records were reviewed with no issues being identified.There were no related quality notifications.All processes and final inspections comply with specification requirements.This complaint has not been confirmed for the indicated failure mode: damaged.Bd has initiated corrective and preventive action to address the reported issue.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 monitoring of current trends.
Event or Problem Description
It was reported while using bd vacutainer® push button blood collection set, the hub of one device was cracked resulting in sample leakage and recollection.Blood got onto the healthcare workers hands.There is no report of the level of ppe worn, post exposure testing or medical intervention.

• 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: 24781968
• Report Number: 9617032-2026-00403
• Device Sequence Number: 6134434
• Product Code: FPA
• UDI-Device Identifier: 30382903673385
• UDI-Public: (01)30382903673385(11)260101(17)271231(10)5353361
• 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): 04/09/2026

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: 367338
• Device Lot Number: 5353361
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/31/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/05/2026
• Supplement Date Received by Manufacturer: 04/09/2026
• Initial Report FDA Received Date: 04/03/2026
• Supplement Report FDA Received Date: 04/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/01/2026
• 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