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

Catalog Number	SSN100255
Medical Device Problem Codes	Disconnection (1171); Dull, Blunt (2407); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/18/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "today i had to go through 4 before i had one that would luerlock onto my vaccine.The caps fly off, we have had 2 instances where the needle itself came off and thankfully we prevented a needle stick injury.Many of the needles "drag" into the skin as if the needle is not sharp.".
Additional Manufacturer Narrative
The customer reported multiple instances during flu clinic and giving immunizations where the needles ¿don¿t luer lock onto the vaccine/syringe,¿ the cap is ¿flimsy and gets in the way,¿ the cap was ¿not staying on when taking out of the package,¿ the needles were ¿not sharp,¿ and a needle ¿flew off the device¿; no needle stick occurred and the impact was ¿provider, having to change the needle, or even having to waste the vaccine.¿ medline received a complaint for 1bx of hypodermic safety needle, documented that the customer was using prefilled syringes with the needles, identified that the reported lot falls under a supplier corrective action for needle disconnecting from prefilled syringes, and material trending via sap showed similar complaints during the last 12 months.The investigation record does not explicitly state that the complaint was confirmed or not confirmed by product evaluation; the cause code documented was ¿comp./part defective, broke¿ under ¿dc:supplier error asia (medline brand).¿ medline stated it was working with its vendor in order to implement the necessary corrective actions, 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, 25GX1
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: nathan bersch ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50873052
• Report Number: 1417592-2026-49411
• Device Sequence Number: 16131160
• Product Code: FMF
• UDI-Device Identifier: 30193489031984
• UDI-Public: 30193489031984
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 09/23/2026

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: 89721090001
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 10/30/2023
• 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: 10/18/2023
• Initial Report FDA Received Date: 09/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown