MAUDE Adverse Event Report: BECTON DICKINSON CANNULA INTERLINK VIAL ACCESS; NEEDLE, HYPODERMIC, SINGLE LUMEN

Catalog Number	303367
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/24/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Material #303367.Lot #4305196.Verbatim: rcc received a complaint via email.For safety awareness, there is a product that is used to draw up vialed solutions.When the rn went to use this item (above), it separated and left a sharp exposed as a safety hazard.Additional information: i do not have an exact date, however i was made aware of the event the morning of 02-24-2025.The event may have occurred during the weekend of or before.All physical samples of the affected product were disposed of in our sharps container to prevent safety hazards.We do not have an exact count of the affected product as this issue was discovered by our clinical team over the weekend & addressed to leadership afterwards.Confirmed (b)(4) ea defective.
Additional Manufacturer Narrative
Initial mdr submission.A follow up mdr will be submitted if additional information, a device evaluation, or a device history review is completed.
Additional Manufacturer Narrative
(b)(4) follow up: it was reported the unit separated and left a sharp exposed.As a physical sample was not returned, a thorough sample evaluation could not be performed.To aid in the investigation, two photos were received for evaluation by our quality team.One photo shows a packaging blister top web.The second photo shows a vial with the blue interlink cannula inserted into a vial stopper.The bottom part of the cannula interlink is not visible.A device history record review was completed for provided material number 303367, lot 4305196.The review did not reveal any detected quality issues during the production of this lot that could have contributed to the reported condition.There were no related quality notifications.All processes and final inspections complied with specification requirements.To date, there have been no other similar events reported for this lot.Based on the investigation with the photo sample analysis the symptom reported by the customer is confirmed.Without the actual physical sample analysis, a probable root cause could not be offered.
Event or Problem Description
No additional information received.

• Brand Name: CANNULA INTERLINK VIAL ACCESS
• Common Device Name: NEEDLE, HYPODERMIC, SINGLE LUMEN
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 21641423
• Report Number: 1911916-2025-00210
• Device Sequence Number: 20813865
• Product Code: FMI
• UDI-Device Identifier: 00382903033676
• UDI-Public: (01)00382903033676(11)241031(17)291231(10)4305196
• 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: Other,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/19/2025

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: 303367
• Device Lot Number: 4305196
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/28/2025
• Supplement Date Received by Manufacturer: 03/19/2025
• Initial Report FDA Received Date: 03/19/2025
• Supplement Report FDA Received Date: 03/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/31/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown