MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; NEEDLE,18GX1.0",REG,BEVEL,ST

Catalog Number	SYR100185
Medical Device Problem Codes	Particulates (1451); Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/10/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that particulates from a medication core leaked into the medication of a multi-dose vial.
Additional Manufacturer Narrative
The reported issue was leaking; per medwatch, it was discovered in the cath lab that particulates from a medication core leaked into the medication of a multi-dose vial.A sample(s) was not received for investigation, and the complaint could only be confirmed by further investigating the sample or a provided photo; additional information was requested from the customer, but no response was received.The complaint was not confirmed.The cause code was updated to reflect dc: traced to user - misuse/mishandling and defect code to needle - coring; according to the product specifications, syr100185 standard hypodermic needles are not designed to penetrate vials.There were no reports of death, serious injury, medical intervention, or follow up care.It has been determined that the reported event could cause or contribute to serious injury if it were to occur again.In an abundance of caution, this is a reportable event.If additional information becomes available this report will be reopened and reevaluated.This medical device report (mdr) is being submitted as part of retrospective review activities, which include review of historical data in accordance with regulations at 21 cfr part 803.The information included in this mdr reflects the information reasonably known to the manufacturer at the time of this retrospective review and submission.

• Brand Name: MEDLINE
• Common Device Name: NEEDLE,18GX1.0",REG,BEVEL,ST
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: kehkashan khan ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50803471
• Report Number: 1417592-2026-43484
• Device Sequence Number: 12986815
• Product Code: FMI
• UDI-Device Identifier: 40080196304944
• UDI-Public: 40080196304944
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K112057
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Type of Report: Initial
• Report Date (Section B): 09/16/2026

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
• Device Catalogue Number: SYR100185
• Device Lot Number: 220820
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/10/2023
• Initial Report FDA Received Date: 09/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown