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

Catalog Number	303346
Medical Device Problem Code	Expiration Date Error (2528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/29/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 bd syringe 3ml ll w/blunt plastic cann label content was incorrect.Verbatim: expired product received.Expiration date: 1-31-2023.
Additional Manufacturer Narrative
(b)(4) - supplemental mdr - label content incorrect.One photo and one sample of a 3 ml luer lok syringe (part number 303346, batch 5035774) were received for evaluation.The photo showed a package with an incorrect expiration date, which does not align with the product established shelf life, and the physical sample confirmed the same issue.This condition is non-conforming per product specifications.An investigation was conducted, including interviews with a controls specialist and a review of production databases and mechanical and electrical records, with no contributing factors identified.However, the device history record review revealed that the incorrect top web slip had been placed as evidence, but the discrepancy was not detected at the time.The likely root cause is linked to the packaging process, specifically an incorrect entry of a secondary human readable date.The complaint will continue to be monitored, and corrective actions taken include issuing a quality alert to the plant and re educating all relevant personnel, followed by a verification of effectiveness to confirm successful training.Complaints received for this device and the reported condition will continue to be tracked and trended.Information will be captured in trend reports and monitored monthly, and our business team regularly reviews the collected data to identify 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: 24290694
• Report Number: 1213809-2026-00050
• Device Sequence Number: 21181534
• Product Code: FMI
• UDI-Device Identifier: 00382903033461
• UDI-Public: (01)00382903033461(17)300131(10)5035774
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K974363
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/06/2026

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: Other
• Device Catalogue Number: 303346
• Device Lot Number: 5035774
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/06/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/20/2026
• Supplement Date Received by Manufacturer: 03/06/2026
• Initial Report FDA Received Date: 02/09/2026
• Supplement Report FDA Received Date: 03/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/04/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown