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

Catalog Number	303405
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	10/24/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B.3.The date received by manufacturer has been used for this field.E.1.Address was not located and il was used.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 the bd syringe 10ml ll w/interlink vac had tip breakage.The following information was provided by the initial reporter: material # 303405, batch # 5169514.Verbatim: physician reported that a blunt plastic cannula broke and stuck her while accessing a vial.She reports that this is the second instance of this happening with this item.Additional information provided: this is the second time i have experienced a break with this device.The first time was 1-2 years ago where i was injured from the plastic breaking.After that point, i have actually stopped using the plastic piece.I traditionally open a separate blunt fill needle for my own safety.This week, i did not have the blunt fill needle readily available and needed to proceed with using the plastic one pre-packaged where i experienced the malfunction.Fortunately, skin was not broken this time.Previous event i had a puncture to my hand that required alterations to scrubbing.I cannot find the photo that i sent to or leadership from the previous event in the last couple years.This time was last monday.For more detail on my injury, i had a laceration that did not require suturing.I used topical agents (dermabond) and tegaderm to cover injury.I performed local wound care with topical wound healing agents.It has a small scar, but no long term issue.I did not require oral antibiotics.This time fortunately the skin was not punctured, but just bruised, so while hurt it was not a barrier to doing my job.
Additional Manufacturer Narrative
(b)(4).- supplemental mdr - tip breakage.As no physical or picture sample, or valid lot number was provided for evaluation, by our quality engineer team, a complete investigation could not be performed.There are current quality controls in place to detect this type of product malfunction during the production process.Based on the limited investigation results, a cause for the reported incident could not be determined.Complaints received for this device and reported condition will continue to be tracked and trended.Our quality team regularly reviews the collected data for identification of 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: 23481189
• Report Number: 1213809-2025-00703
• Device Sequence Number: 10330104
• Product Code: FMI
• UDI-Device Identifier: 00382903034055
• UDI-Public: (01)00382903034055(17)300531(10)5169514
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K924439
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/15/2026

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: Health Professional
• Device Catalogue Number: 303405
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/24/2025
• Supplement Date Received by Manufacturer: 12/02/2025
• Initial Report FDA Received Date: 11/05/2025
• Supplement Report FDA Received Date: 01/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/18/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown