MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; DBQ CED-SYRINGE, LUER LOCK, STERILE,10ML

Catalog Number	SYR110010Z
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/12/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "i have a box of 10cc syringes that have some damaged ones, it looks like about 20 ea" and "it's the side of the syringe that is broken, they are still in the package but you can see the side handle broken.".
Additional Manufacturer Narrative
The customer reported a box of 10cc syringes had "some damaged ones" and "the side of the syringe that is broken," with the syringes still in the package and the side handle broken.Medline received 22 ea medline sterile luer lock syringes and, upon visual investigation, noticed that some of the syringes were broken at the right wing of the syringe inside the packaging; the vendor reviewed retained samples and dhr records, with no abnormalities found in retained samples or records.The complaint was confirmed.The cause code was updated to defect confirmed: unknown responsible party, cannot determine cause w/received sample, and the 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: DBQ CED-SYRINGE, LUER LOCK, STERILE,10ML
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: rylee rosenberg ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50948551
• Report Number: 1417592-2026-54616
• Device Sequence Number: 9499289
• Product Code: FMF
• UDI-Device Identifier: 30080196310191
• UDI-Public: 30080196310191
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: K061275
• 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): 09/29/2026

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: SYR110010Z
• Device Lot Number: 89723050002
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/26/2024
• 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: 03/12/2024
• Initial Report FDA Received Date: 09/30/2026
• 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