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

Catalog Number	303367
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/20/2025
Type of Reportable Event	Malfunction
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.The actual date of event is unknown.The date received by manufacturer was entered into the date of event field.
Event or Problem Description
Material #303367 lot #unknown verbatim: rcc received a complaint via email.Email(s) attached.We have had some instances of this vial cannula #303367 either lot #4159426; or #4305196.Of these having some kind of explosion when trying to load a fentanyl vial into a syringe additional information hi.They were glass vials with silicone (?) areas that you puncture to draw up the solution.And the silicone didn't suction around the blunt tip so it leaked out around the puncture.Normally it creates a seal and when you draw out the blunt tip it is completely closed, with these blunt tips it remained a hole.It happened in fentanyl and lidocaine vials now.
Additional Manufacturer Narrative
(b)(4) follow up: it was reported there was no suction around the blunt tip, so the medication leaked out around the puncture.As a sample was not returned, a thorough sample evaluation could not be performed.A device history record review was completed for provided material number 303367, possible lot numbers 4159426 and 4305196.The reviews did not reveal any detected quality issues during the production of these lots that could have contributed to the reported defect.There were no related quality notifications.All processes and final inspections complied with specification requirements.Based on the investigation results, an exact cause for this incident could not be identified.Should you again experience any problems with our product we would appreciate the opportunity to conduct a thorough analysis.Further action has not been determined necessary at this time.
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: 21514250
• Report Number: 1911916-2025-00176
• Device Sequence Number: 11909910
• Product Code: FMI
• UDI-Device Identifier: 00382903033676
• UDI-Public: (01)00382903033676(11)240607(17)290731(10)4159426
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K924439
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/08/2025

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: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/20/2025
• Supplement Date Received by Manufacturer: 03/07/2025
• Initial Report FDA Received Date: 03/04/2025
• Supplement Report FDA Received Date: 03/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/07/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown