MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; NEEDLE,22GX1.5",REG,BEVEL

Catalog Number	SYR100227Z
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/26/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that syr100227z have holes in the caps at the end of the needles, which makes them non-sterile.
Additional Manufacturer Narrative
The customer reported holes in the caps at the end of the needles, which makes them non-sterile.Medline received 1bx, syr100227z standard hypodermic needle in new condition.The complaint was not confirmed, and the cause code was updated to reflect dc: traced to user - preference/item to spec.Medline concluded this is not a quality issue, the item is sterile in the packaging, and any holes/slits in the cap have no impact on sterility.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,22GX1.5",REG,BEVEL
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: raveena sampathi ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50882802
• Report Number: 1417592-2026-49737
• Device Sequence Number: 9826600
• Product Code: FMI
• UDI-Device Identifier: 30080196305531
• UDI-Public: 30080196305531
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K233037
• 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): 09/23/2026

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: SYR100227Z
• Device Lot Number: 221205
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/06/2023
• 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: 05/26/2023
• Initial Report FDA Received Date: 09/24/2026
• Was Device Evaluated by Manufacturer? (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