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 Code	Difficult or Delayed Activation (2577)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/11/2025
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 after using bd vacutainer® safety-lok¿ blood collection set with pre-attached holder, the healthcare provider had difficulty activating the safety cover in an unspecified number of devices.No adverse impact was reported regarding the patient or user.
Event or Problem Description
It was reported after using bd vacutainer® safety-lok¿ blood collection set with pre-attached holder, the the healthcare provider had difficulty activating the safety cover in an unspecified number of devices.No adverse impact was reported regarding the patient or user.
Additional Manufacturer Narrative
After further evaluation of the complaint, it has been determined that the previously submitted report 1024879-2025-02045 was sent in error as it was already previously reported in of mfr report # 1024879-2025-02044.

• 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: 23771017
• Report Number: 1024879-2025-02045
• Device Sequence Number: 21490566
• Product Code: JKA
• UDI-Device Identifier: 00382903686544
• UDI-Public: (01)00382903686544(11)250501(17)270430(10)5142199
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• 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,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/10/2026

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: 5142199
• 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: 11/13/2025
• Supplement Date Received by Manufacturer: 03/10/2026
• Initial Report FDA Received Date: 12/10/2025
• Supplement Report FDA Received Date: 03/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/01/2025
• 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