MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; NEEDLE,HYPODERM,SAFETY,25GX1.5

Catalog Number	SSN100257Z
Medical Device Problem Codes	Disconnection (1171); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/22/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "it was happening with our pre-drawn influenza vaccines and was leaking from the luer connector" and "one needle detached and was left in a patient's arm.".
Additional Manufacturer Narrative
The customer reported that with pre-drawn influenza vaccines the needle ¿was leaking from the luer connector,¿ and that at a flu clinic ¿one needle detached and was left in a patient's arm.¿ medline received a complaint for the hypodermic safety needle, noted the customer advised that they were using prefilled syringes with the needles, and material trending via sap showed similar complaints during the last 12 months.Due diligence was completed; no additional details are available related to the customer reported issue, and no medical intervention, serious injury, or follow-up care has been reported.The cause was documented as ¿dc:supplier error asia (medline brand)¿ and ¿comp./part defective, broke¿; medline stated it is working with the vendor to implement the necessary corrective actions 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,25GX1.5
• 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: 50817818
• Report Number: 1417592-2026-44541
• Device Sequence Number: 18673881
• Product Code: FMF
• UDI-Device Identifier: 20193489031994
• UDI-Public: 20193489031994
• 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): 09/17/2026

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: SSN100257Z
• Device Lot Number: 89721090001
• 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: 03/22/2023
• Initial Report FDA Received Date: 09/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/01/2021
• 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