MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL INTERLINK LUER-LOK; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	303367
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/03/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported by the customer that vial access cannula breaking in half.No patient harm.
Additional Manufacturer Narrative
(b)(4) follow up for device evaluation.The customer reported that the cannula was breaking and that the rubber stopper was being depressed into the vial.To support the investigation, seven samples and four photographs were received for evaluation by the quality team.Two samples arrived in sealed blister packaging and five arrived without blister packaging, one additional empty, opened blister was also received.A visual inspection was performed.Four of the samples without blister packaging exhibited damage at the top of the needle hub, the remaining three samples showed no damage.Approximately 1 32 inch below the top of the needle hub, marks or indentations were observed at each rib that appear consistent with tooling contact.The manufacturing process is fully automated and does not include any conditions that would generate such marks.No defects or imperfections were observed on the sharp spike.The four photographs provided show the samples received.Please note, these products are intended for use with pre slit interlink injection sites and are not compatible with conventional injection sites.A device history record review was completed for material number 303367, lot 5267530.The review did not identify any quality issues during manufacturing that could have contributed to the reported condition.There were no related quality notifications, and all processes and final inspections met specification requirements.Based on the investigation and analysis of the returned samples, the customer reported condition is confirmed.

• Brand Name: INTERLINK LUER-LOK
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• 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: 24567917
• Report Number: 1911916-2026-00111
• Device Sequence Number: 9417585
• Product Code: FMI
• UDI-Device Identifier: 00382903033676
• UDI-Public: (01)00382903033676(17)300930(10)5267530
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/13/2026

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: 303367
• Device Lot Number: 5267530
• 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: 03/03/2026
• Supplement Date Received by Manufacturer: 03/13/2026
• Initial Report FDA Received Date: 03/11/2026
• Supplement Report FDA Received Date: 03/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/24/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown