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

Catalog Number	303367
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/03/2025
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.
Event or Problem Description
Material#: 303367.Batch#: 4247046.Verbatim: sue, was advised to reach out to you regarding an issue you have been dealing with at xxxx.Centracare ems (ambulance) in xxxx has had 2 vials of fentanyl that were punctured using the new (sub safety blunt needle) and when doing so, the vial rubber stops either pushed into the vial or blew the seal and the medication poured out of the vial.This incident is being vetted by our managers and clare to assure no foul play, but it doesn¿t appear to be the case.2 sperate medics, and it appears that there was no previous tampering.1.Any adverse event or serious injury reported to patient or healthcare professional? if yes, please provide the details.No.2.Can you please provide an exact date of event in format dd-mmm-yyyy? 01-03-2025.3.Can you please provide the needle material and lot number associated with reported issue? plastic.Lot # 4247046.
Additional Manufacturer Narrative
(b)(4) follow up.A device history record review was completed by our quality engineer team for provided material number 303367 and lot number 4247046.The review did not reveal any detected abnormalities during the production process that could have contributed to this defect and all quality tests were found to be within specification.As a sample was unavailable for return, a thorough sample investigation could not be completed.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.There are quality controls currently in place to detect this type of defect during the production process.Further action has not been determined necessary at this time.

• 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: 21649325
• Report Number: 1911916-2025-00213
• Device Sequence Number: 20689018
• Product Code: FMI
• UDI-Device Identifier: 00382903033676
• UDI-Public: (01)00382903033676(11)240903(17)291130(10)4247046
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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): 03/26/2025

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: 4247046
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/03/2025
• Supplement Date Received by Manufacturer: 03/26/2025
• Initial Report FDA Received Date: 03/19/2025
• Supplement Report FDA Received Date: 03/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/03/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown