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

Catalog Number	SYR100185
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/23/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "our staff are reporting multiple events of coring when they use these needles to draw up solutions in the iv room." "coring" is when part of the rubber stopper on a drug vial dislodges from the core, or a piece of the stopper is sheared off, and goes into the drug liquid in the vial.
Additional Manufacturer Narrative
The customer reported multiple events of coring when the needles were used to draw up solutions in the iv room, and stated that part of the rubber stopper on a drug vial dislodges from the core, or a piece of the stopper is sheared off, and goes into the drug liquid in the vial.Medline received 2 boxes of syr100185 standard hypodermic needles in new condition and additional information was requested from the customer; the customer advised that these needles were used to draw up medication from a vial.The complaint was not confirmed.According to the product specifications, syr100185 standard hypodermic needles are not designed to penetrate vials, and the cause code was updated to reflect traced to user - misuse/mishandling; there was no change to the reportability decision associated with this complaint.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: shravan ingole ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50797370
• Report Number: 1417592-2026-43175
• Device Sequence Number: 10529390
• Product Code: FMI
• UDI-Device Identifier: 40080196304944
• UDI-Public: 40080196304944
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 09/15/2026

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: 220610
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/02/2023
• 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: 05/25/2023
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown