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

Catalog Number	303405
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/13/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E.1.Address was not located and (b)(6) 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) follow up for device evaluation: a blunt plastic cannula reportedly fractured while accessing a vial.To support the investigation, one sample in an opened blister package without the plastic shield was received by the quality team for evaluation.Visual inspection found the plastic cannula fractured at the top of the hub and bent approximately 90 degrees.No additional defects or imperfections were observed.This condition may occur when the plastic component is subjected to excessive mechanical stress.A device history record review was completed for material number 303405, lot 5169514.The review confirmed that all required visual inspections were performed with no quality notifications related to the reported condition.The lot was inspected and accepted per the inspection control plan and subsequently approved for shipment.Device histories for each cannula lot used in manufacturing this finished lot were also reviewed; no documentation of this defect type was identified during the production of these batches.To date, no other similar events have been reported for this lot.Based on the investigation, including analysis of the returned sample, the customer reported symptom is confirmed.

• Brand Name: BD 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: 23481187
• Report Number: 1213809-2025-00702
• Device Sequence Number: 16034812
• Product Code: FMI
• UDI-Device Identifier: 00382903034055
• UDI-Public: (01)00382903034055(17)300531(10)5169514
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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: 5169514
• 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: 10/15/2025
• Supplement Date Received by Manufacturer: 01/15/2026
• Initial Report FDA Received Date: 11/05/2025
• Supplement Report FDA Received Date: 01/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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