MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; GREEN,SYRINGE,EAR/ULCER, 3 OZ, STERILE

Catalog Number	DYND70277
Medical Device Problem Codes	Suction Problem (2170); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/30/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "the item has little to no suction and they they are very hard to squeeze.".
Additional Manufacturer Narrative
The customer stated that the item has little to no suction and they they are very hard to squeeze.Medline quality received returned product in packaged, unused condition; visual assessment revealed no defects or abnormalities, and functional testing was conducted by comparing the stiffness of the product to samples from another lot.The reported issue of stiffness and lack of suction was confirmed based on functional inspection of the received samples and the investigation performed by the manufacturer.The reported lot failed the hardness test, exceeding the requirements, and the root cause has been determined to be the raw material exceeding the hardness requirements; the manufacturer issued a scar to their supplier and implemented hardness testing inspection procedures when receiving the raw material and for the finished product, and medline quality will continue to monitor these corrective actions for effectiveness.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: GREEN,SYRINGE,EAR/ULCER, 3 OZ, STERILE
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: william abrams ; three lakes drive; northfield, IL 60093
• MDR Report Key: 50854264
• Report Number: 1417592-2026-47476
• Device Sequence Number: 18655323
• Product Code: KYZ
• UDI-Device Identifier: 40080196862543
• UDI-Public: 40080196862543
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• 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): 09/21/2026

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: DYND70277
• Device Lot Number: 96924030001
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/16/2024
• 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: 07/30/2024
• Initial Report FDA Received Date: 09/22/2026
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown