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

Catalog Number	SYR100185
Medical Device Problem Code	Off-Label Use (1494)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/08/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "when inserting the needle into the medication, the rubber top is breaking and going into the solution bottle.".
Additional Manufacturer Narrative
The customer reported concern regarding standard hypodermic needles not working properly, described as the rubber top breaking and going into the solution bottle when inserting the needle into the medication.Medline received 1cs standard hypodermic needles in new condition, and according to the product specifications, the hypodermic-regular bevel needles are not designed to penetrate medical vials.The complaint was not confirmed, and this issue can be classified as off-label usage with the cause code updated to reflect 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,18GX1.0",REG,BEVEL,ST
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: rizwan shaik ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50752730
• Report Number: 1417592-2026-38996
• Device Sequence Number: 9414779
• Product Code: FMI
• UDI-Device Identifier: 40080196304944
• UDI-Public: 40080196304944
• Combination Product (Y/N): N
• Initial Reporter State: UT
• 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): 09/09/2026

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: 230401
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/25/2024
• 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: 03/08/2024
• Initial Report FDA Received Date: 09/14/2026
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown