MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; NEEDLE,HYPODERM,SAFETY,21GX1.5

Catalog Number	SSN100217
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/16/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the caps on safety needle 21g x 1.5 are not properly attached to the needle.
Additional Manufacturer Narrative
The customer reported that the caps on the safety needle 21g x 1.5 are not properly attached to the needle, and the customer replied the syringes are not prefilled.Medline received 1bx of ssn100217 hypodermic safety needle in new condition, randomly selected 25 samples for visual and functional testing, dispensed 1ml of water from each syringe/needle, and reviewed material trending via sap.A visual inspection revealed no manufacturing defects, functional testing was unable to create the same issue, the caps stayed firmly on the needle, the flow was continuous, and material trending showed no similar complaints during the last 12 months.The complaint was not confirmed, and no root cause was identified.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,HYPODERM,SAFETY,21GX1.5
• 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: 50801969
• Report Number: 1417592-2026-43265
• Device Sequence Number: 21476719
• Product Code: FMF
• UDI-Device Identifier: 30193489031922
• UDI-Public: 30193489031922
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K213054
• 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: SSN100217
• Device Lot Number: 10)89722010001
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/30/2023
• 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: 08/16/2023
• 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