MAUDE Adverse Event Report: BECTON DICKINSON & CO (FRANKLIN LAKES) BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET; TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION

Catalog Number	367297
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/24/2026
Type of Reportable Event	Malfunction
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.D.9: returned to manufacturer on: 15-apr-2026.G.4.Pma / 510(k)#: k252506.Investigation summary: bd received five customer samples and two photos for evaluation.Review of the photos did not display the reported failure mode of insufficient blood flow for the incident lot.The five customer samples, along with 50 retention samples from bd inventory, were evaluated through visual examination, and no issues related to insufficient blood flow were observed, all samples met applicable specifications.Also, the five customer samples, together with eight retention samples from bd inventory, were evaluated by functional testing, and no issues associated with insufficient blood flow were identified, all samples met specifications.A review of the device history record (dhr) for the incident lot confirmed that all product specifications and lot release requirements were met, with no related quality issues identified during manufacturing.Based on the available information, this complaint could not be confirmed for the reported failure mode of insufficient blood flow, and no root cause could be identified.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.
Event or Problem Description
It was reported while using bd vacutainer® safety-lok¿ blood collection set, resistance is seen during blood draw using an unspecified number of devices.When the nurse engages the yellow needle shield, any blood that is in the tubing shoots out of the needle.No adverse impact was reported regarding the patient or user.
Additional Manufacturer Narrative
The manufacturing location for this product is (nipro).This site is an oem manufacturing site.Therefore, bd corporate headquarters in franklin lakes, nj has been listed in sections d.3.And g.1.And the franklin lakes fda registration number has been used for the manufacture report number.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® safety-lok¿ blood collection set, resistance is seen during blood draw using an unspecified number of devices.When the nurse engages the yellow needle shield, any blood that is in the tubing shoots out of the needle.No adverse impact was reported regarding the patient or user.

• Brand Name: BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET
• 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 & CO (FRANKLIN LAKES); 1 becton drive; franklin lakes NJ 07417
• Manufacturer Contact: anand singh ; 1 becton drive; franklin lakes, NJ 07417 ; 2018475186
• MDR Report Key: 24778572
• Report Number: 2243072-2026-00254
• Device Sequence Number: 15961557
• Product Code: JKA
• UDI-Device Identifier: 30382903672975
• UDI-Public: (01)30382903672975(17)280831(10)25J2581
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K980414
• 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): 05/07/2026

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: 367297
• Device Lot Number: 25J2581
• 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: 03/04/2026
• Supplement Date Received by Manufacturer: 05/07/2026
• Initial Report FDA Received Date: 04/03/2026
• Supplement Report FDA Received Date: 05/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/18/2025
• 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