MAUDE Adverse Event Report: BECTON DICKINSON & CO (FRANKLIN LAKES) BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET PRE-ATTACHED HOLDER; BLOOD SPECIMEN COLLECTION DEVICE

Catalog Number	368654
Medical Device Problem Codes	Difficult or Delayed Activation (2577); Packaging Problem (3007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 prior to using bd vacutainer® safety-lok¿ blood collection set with pre-attached holder, there was 10 devices that had an open seal and an unspecified number of needles had safety shield issues.No adverse impact was reported regarding the patient or user.
Event or Problem Description
It was reported prior to using bd vacutainer® safety-lok¿ blood collection set with pre-attached holder, there was 10 devices that had an open seal and an unspecified number of needles had safety shield issues.No adverse impact was reported regarding the patient or user.
Additional Manufacturer Narrative
Investigation summary: investigation summary bd did not receive any samples or photos for investigation.Therefore, 30 retained samples were visually inspected for open or damaged packaging, damaged safety shields, and needle point integrity.All samples passed testing as the seals were complete with no damage to the packaging, safety shields were present with no evidence of damage, and there was no evidence of poor needle point integrity.Additionally, the 30 retain samples were subjected to sleeve function testing and all samples passed testing as there was no evidence of damage to the device or leakage during use.Furthermore, 10 of the retain samples were subjected to a test for lube coverage.All the samples passed testing exhibiting sufficient lube coverage on the iv cannula.Based on a review of the device history record for the incident lot, all product specifications and requirements for lot release were met.This complaint has not been confirmed for the indicated failure modes: difficult/unable to operate and open package/seal.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 the identification of emerging trends.

• Brand Name: BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET PRE-ATTACHED HOLDER
• Common Device Name: BLOOD SPECIMEN COLLECTION DEVICE
• 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: 23822254
• Report Number: 1024879-2025-02137
• Device Sequence Number: 13252730
• Product Code: JKA
• UDI-Device Identifier: 00382903686544
• UDI-Public: (01)00382903686544(11)250505(17)270331(10)5107834
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/07/2026

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: 368654
• Device Lot Number: 5107834
• 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: 11/20/2025
• Supplement Date Received by Manufacturer: 04/07/2026
• Initial Report FDA Received Date: 12/16/2025
• Supplement Report FDA Received Date: 04/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/05/2025
• 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