MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; NEEDLE,20GX1.5 ,REG,BEVEL

Catalog Number	SYR100207Z
Medical Device Problem Codes	Material Twisted/Bent (2981); Difficult or Delayed Separation (4044)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	05/30/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "needle cap is difficult to remove and appears to stick at the base of the needle and when removing with necessary force creates a clean needle stick situation".
Additional Manufacturer Narrative
The customer reported cap issues with a medline hypodermic needle 20g1.5 in which the needle cap was difficult to remove and appeared to stick at the base of the needle and a vanishpoint need (b)(6), in which the needle was bending when used.A sample was not received for investigation; however, a lot number/serial number was recorded, and the investigation included review of the lot/serial number and recent complaint trends/scar activity for the past 12 months.The complaint was not confirmed because the issue can only be confirmed by further investigating the sample or a provided photo, and the cause was sample required to determine cause.There were no prior complaints in regards to this issue, no known trends for this product or lot, and the division will continue to monitor the issue for trending.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,20GX1.5 ,REG,BEVEL
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: donovan frazier ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50802768
• Report Number: 1417592-2026-43352
• Device Sequence Number: 21480229
• Product Code: FMI
• UDI-Device Identifier: 30080196305487
• UDI-Public: 30080196305487
• Combination Product (Y/N): N
• Initial Reporter State: VT
• 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): 09/15/2026

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: SYR100207Z
• Device Lot Number: 220615
• Was Device Available for Evaluation?: Yes
• 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: 05/30/2024
• Initial Report FDA Received Date: 09/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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