MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; NEEDLE,HYPODERM,SAFETY,18GX1.5

Catalog Number	SSN100187
Medical Device Problem Codes	Particulates (1451); Off-Label Use (1494)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/13/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "these needles have been coring the tops of medication vials, resulting in tiny plastic particles being released into the vial or the drawing syringe.".
Additional Manufacturer Narrative
The customer reported that the needles have been coring the tops of medication vials, resulting in tiny plastic particles being released into the vial or the drawing syringe, and medication needed to be wasted and a new replacement pulled from the pyxis.Medline received 7bx standard hypodermic needles in new condition; per account details, the samples are used to draw medication, and the samples worked as intended.The complaint was not confirmed.According to the customer, "it seems we used the wrong needle and appears to be an internal issue"; hypodermic needles are not designed to penetrate vials, and the cause code was updated to reflect dc: traced to user - misuse/mishandling; the division has been informed and will continue to monitor trends.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,HYPODERM,SAFETY,18GX1.5
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: aaron ginsburg ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50801901
• Report Number: 1417592-2026-43258
• Device Sequence Number: 18367789
• Product Code: FMI
• UDI-Device Identifier: 30193489031878
• UDI-Public: 30193489031878
• Combination Product (Y/N): N
• Initial Reporter State: WY
• Initial Reporter Country: US
• PMA/510(K) Number: K213054
• 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: SSN100187
• Device Lot Number: 89723110001
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/28/2024
• 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: 05/13/2024
• Initial Report FDA Received Date: 09/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown