MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; NEEDLE,30GX0.5"REG,BEVEL

Catalog Number	SYR100302
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	06/27/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "the needle bent, and poked her finger through the cap.".
Additional Manufacturer Narrative
According to the customer on (b)(6) 2023 when placing the cap on a needle, the needle bent and "poked her finger through the cap"; due to this, the provider required lab work be done, and no additional medical intervention was reported and no serious injury was reported related to the incident.Medline received one standard hypodermic needle in used condition, and upon a visual inspection of the sample, did see the needle sticking out through the needle cap.The complaint was confirmed, and the issue shown was caused due to the recapping of a dirty needle.Material trending via sap showed no similar complaints during the last 12 months, and 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,30GX0.5"REG,BEVEL
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: abdul khan ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50816899
• Report Number: 1417592-2026-44487
• Device Sequence Number: 15991905
• Product Code: FMI
• UDI-Device Identifier: 40080196305637
• UDI-Public: 40080196305637
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 09/17/2026

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: SYR100302
• Device Lot Number: 220922
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/11/2023
• 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: 06/29/2023
• Initial Report FDA Received Date: 09/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/01/2022
• 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: Reuse
• Patient Sequence Number: 1
• Patient Age: 30 YR
• Patient Sex: Female
• Patient Weight: 145 LB