MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; NEEDLE,HYPODERM,SAFETY, 30GX0.5

Catalog Number	SSN100302Z
Medical Device Problem Codes	Break (1069); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/13/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "the needles are bending/breaking.".
Additional Manufacturer Narrative
The reported product problem/issue was bending/breaking of the needles.Medline received 1bx medline hypodermic needle in new condition, randomly selected 25 samples for visual and functional testing, attached each needle to a medline syringe, and inserted each needle into an injection pad; no manufacturing defects were seen, each needle remained attached to its needle hub without bending or breaking while adding excessive force, and the samples performed as intended.The complaint was not confirmed; the cause code was unconfirmed defect, not confirmed with received sample.A retrospective review indicated 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,HYPODERM,SAFETY, 30GX0.5
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: kehkashan khan ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50804161
• Report Number: 1417592-2026-43619
• Device Sequence Number: 18278536
• Product Code: FMF
• UDI-Device Identifier: 20193489032038
• UDI-Public: 20193489032038
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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): 09/16/2026

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: SSN100302Z
• Device Lot Number: 89724010001
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/15/2024
• 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: 08/13/2024
• 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