MAUDE Adverse Event Report: BECTON DICKINSON & CO (FRANKLIN LAKES) BD VACUTAINER® MULTIPLE SAMPLE LUER ADAPTER; TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION

Catalog Number	367290
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	12/31/2025
Type of Reportable Event	Serious Injury
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
Report 2 of 2: it was reported while using bd vacutainer® multiple sample luer adapter, one nurse experienced a dirty needlestick with the np needle after the holder broke off.No treatment was required.There was no other health impact or consequences reported.The following information was provided by the initial reporter: "the vacutainer was used to draw labs and the vacutainer got stuck on the port and was unable to be removed.The plastic guard broke off and while continuing to try to remove the vacutainer, the needle stuck the rn.No treatment needed except for lab work drawn on patients and staff.".
Additional Manufacturer Narrative
Investigation summary:bd received 2 photos for investigation.The provided photos show two sealed luer adapters with labeling, but they are not connected to a device; no defects were noted.Additionally, a total of 30 retained samples were visually inspected for damage to the cannula and hub, and all samples passed as there were no signs of damage.Furthermore, 20 retained samples underwent functional tests for cannula pull out, and all samples passed as there was no cannula pull out.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 in unable to be confirmed.Based on the investigation completed, no root cause from manufacturing was identified as a contributor.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
Report 2 of 2: it was reported while using bd vacutainer® multiple sample luer adapter, one nurse experienced a dirty needlestick with the np needle after the holder broke off.No treatment was required.There was no other health impact or consequences reported.The following information was provided by the initial reporter: "the vacutainer was used to draw labs and the vacutainer got stuck on the port and was unable to be removed.The plastic guard broke off and while continuing to try to remove the vacutainer, the needle stuck the rn.No treatment needed except for lab work drawn on patients and staff.".

• Brand Name: BD VACUTAINER® MULTIPLE SAMPLE LUER ADAPTER
• 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: 24203741
• Report Number: 1024879-2026-00052
• Device Sequence Number: 20204647
• Product Code: JKA
• UDI-Device Identifier: 30382903672906
• UDI-Public: (01)30382903672906(11)250801(17)280731(10)5232655
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K243649
• 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): 03/17/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Other
• Device Catalogue Number: 367290
• Device Lot Number: 5232655
• 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: 12/31/2025
• Supplement Date Received by Manufacturer: 03/17/2026
• Initial Report FDA Received Date: 01/28/2026
• Supplement Report FDA Received Date: 04/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown