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

Catalog Number	368654
Medical Device Problem Code	Short Fill (1575)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/26/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported while using bd vacutainer® safety-lok¿ blood collection set pre-attached holder, insufficient blood flows through one device as a result of a hooked needle used during blood draw.No adverse impact was reported regarding the patient or user.
Additional Manufacturer Narrative
A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Additional Manufacturer Narrative
Investigation summary: bd received 1 photo for investigation.The photo was reviewed and the indicated failure mode for needle point integrity was observed (the needle point was hooked).Insufficient blood flow cannot be evaluated through photo analysis.Additionally, 30 retention samples were subjected to a visual inspection for all cannula defects, including bent cannula and needle point integrity.All samples passed testing with no evidence of damage to the cannula or poor needle point integrity.In addition, 10 of the retain samples were subjected to a test for lube coverage.All samples passed testing exhibiting sufficient lube coverage on the iv cannula.Furthermore, 30 retain samples were subjected to sleeve function testing using 10 tubes per needle to assess functionality of the device.Upon inspection, there was no evidence of damage to the device, leakage, or insufficient blood flow during use.However, one of the samples failed testing as there was tube push off observed on the first tube.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.This complaint has been confirmed for the following defects: needle point integrity, and tube push off.This complaint is unable to be confirmed for insufficient blood flow.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.
Event or Problem Description
It was reported while using bd vacutainer® safety-lok¿ blood collection set pre-attached holder, insufficient blood flows through one device as a result of a hooked needle used during blood draw.No adverse impact was reported regarding the patient or user.

• Brand Name: BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET PRE-ATTACHED HOLDER
• 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., (BD); 1575 airport road; sumter SC 29153
• Manufacturer Contact: anand singh ; 1 becton drive; franklin lakes, NJ 07417 ; 2018475186
• MDR Report Key: 24421648
• Report Number: 1024879-2026-00240
• Device Sequence Number: 5939464
• Product Code: JKA
• UDI-Device Identifier: 30382903686545
• UDI-Public: (01)30382903686545(17)270630(10)5198436
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• 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,Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/28/2026

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: 368654
• Device Lot Number: 5198436
• 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: 01/26/2026
• Supplement Date Received by Manufacturer: 04/28/2026
• Initial Report FDA Received Date: 02/23/2026
• Supplement Report FDA Received Date: 05/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/05/2025
• 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