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	368653
Medical Device Problem Code	Component Misassembled (4004)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/03/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3: date of event is unknown.The date received by manufacturer has been used for this field.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 pre-attached holder, there were an unspecified amount of incorrect devices mixed into the devices received.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: 21-apr-2026.Investigation summary: bd received three samples and ten photos for investigation.Among the photos, three show the device with severed tubing inside the package, three display the device out of the package with severed tubing, one photo highlights foreign matter on the wing of the device, two photos present the top web labeling of the device packaging, and one photo depicts damage to the top web labeling.A visual inspection was performed on the three returned samples, revealing foreign matter on the iv cannula of one sample and damaged, severed tubing on two samples.No samples were found with mixed product.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 been confirmed for the indicated failure modes: severed and foreign matter - non-biological.This complaint has not been confirmed for the indicated failure modes: empty/missing and mixed product.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.
Event or Problem Description
It was reported prior to using bd vacutainer® safety-lok¿ blood collection set pre-attached holder, there were an unspecified amount of incorrect devices mixed into the devices received.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: 24513560
• Report Number: 1024879-2026-00278
• Device Sequence Number: 10298054
• Product Code: JKA
• UDI-Device Identifier: 30382903686538
• UDI-Public: (01)30382903686538(17)270731(10)5238126
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 05/04/2026

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: 368653
• Device Lot Number: 5238126
• 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: 02/03/2026
• Supplement Date Received by Manufacturer: 05/04/2026
• Initial Report FDA Received Date: 03/04/2026
• Supplement Report FDA Received Date: 05/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/01/2025
• 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