MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS INTERLINK LUER-LOK; NEEDLE, HYPODERMIC, SINGLE LUMEN

Catalog Number	303393
Medical Device Problem Code	Labelling, Instructions for Use or Training Problem (1318)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/23/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Event or Problem Description
It was reported that bd syringe 10ml ll w/twinpak device label content was incorrect.Rcc received a complaint via phone.Case description: customer called on behalf of one of her clients, she states that the client bought the 5cc syringes but what she received was the 10cc syringes, on the outer part of the box, it says 5cc.Product: bd twinpak dual cannula device with 5 ml syringe.Ref#: (b)(4).Lot#: 5065846.Customer response on (b)(6) 2026.Can you please provide an exact date of event in format mm-dd-yyyy? this was reported to us on (b)(6) 2026.Could you please confirm if any samples are available for return so we can investigate further? yes the customer has the product.
Additional Manufacturer Narrative
(b)(4).Label content incorrect.One hundred samples of 10 ml twinpak syringes (part number 303393), batch 5065846, were received and evaluated.All samples were received in sealed packages within a single carton.While the packages contained the correct 10 ml syringes, all displayed 5 ml top web graphics, which is considered nonconforming per product specifications.The apparent root cause is related to the packaging process, and a corrective and preventive action (capa) has been initiated to address this issue.Additionally, a device history record review for lot 5065846 identified no rejected inspections or quality issues during production that could have contributed to the reported condition.Complaints related to this device and condition will continue to be tracked and trended, with data captured in monthly trend reports and regularly reviewed to identify any emerging trends.
Event or Problem Description
No additional information was provided.

• Brand Name: INTERLINK LUER-LOK
• Common Device Name: NEEDLE, HYPODERMIC, SINGLE LUMEN
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• Manufacturer (Section G): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 24640120
• Report Number: 1213809-2026-00134
• Device Sequence Number: 9797577
• Product Code: FMI
• UDI-Device Identifier: 00382903033928
• UDI-Public: (01)00382903033928
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K974006
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/27/2026

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: 303393
• Device Lot Number: 5065846
• 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: 02/27/2026
• Supplement Date Received by Manufacturer: 04/27/2026
• Initial Report FDA Received Date: 03/19/2026
• Supplement Report FDA Received Date: 04/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/06/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown