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

Catalog Number	SSN100255
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/22/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "multiple times when administering a vaccine and the needle would come unscrewed from the syringe/immunization and stay in the patients arm or leg, and the syringe in their hand.Also, another time the immunization liquid came out when pushing the plunger through the syringe.".
Additional Manufacturer Narrative
The customer reported that when administering a vaccine, the needle would come unscrewed from the syringe/immunization and stay in the patients arm or leg, and another time the immunization liquid came out when pushing the plunger through the syringe; this occurred four times total.Medline received a complaint for item ssn100255, 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.The investigation results were confirmed, and the documented cause was "comp./part defective, broke." the division has been informed and will continue to monitor trends; no medical intervention, serious injury, or follow-up care has been reported.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
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: rizwan shaik ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50945379
• Report Number: 1417592-2026-54066
• Device Sequence Number: 15827390
• Product Code: FMF
• UDI-Device Identifier: 30193489031984
• UDI-Public: 30193489031984
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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): 09/28/2026

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: SSN100255
• Device Lot Number: 89721070001
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/24/2024
• 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: 05/22/2024
• Initial Report FDA Received Date: 09/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/01/2021
• 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