MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP MEDLINE; 60ML ENFIT SYRINGE, STERILE

Catalog Number	NON66160H
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/03/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that in "mid december" multiple 60ml syringes "were found to be defective.The customer reported that the syringes were "unusable" and that the "plunger is so tight in the housing that it is difficult to move the piston to load/unload the syringe." the customer also stated that the "plunger simply comes off the stem while i am loading the syringe" and "when depressing the plunger." the customer said that it requires "an enormous amount of force" to move the plunger leading to "little to no control of the amount being provided." the customer reported that they "switched to other non-medline syringes." to date, no information has been received to indicate that a user or a patient experienced a death, serious injury, medical intervention, follow-up care, or other adverse health impact associated with the reported problem/issue.In an abundance of caution, and in response to an fda 483 issued for cfn (b)(4) on (b)(6) 2024, this medwatch is being filed for the reported problem/issue.If additional relevant information becomes available a supplemental medwatch will be filed.
Event or Problem Description
It was reported that in "mid december" multiple 60ml syringes "were found to be defective.The customer reported that the syringes were "unusable" and that the "plunger is so tight in the housing that it is difficult to move the piston to load/unload the syringe." the customer also stated that the "plunger simply comes off the stem while i am loading the syringe" and "when depressing the plunger." the customer said that it requires "an enormous amount of force" to move the plunger leading to "little to no control of the amount being provided." the customer reported that they "switched to other non-medline syringes.".

• Brand Name: MEDLINE
• Common Device Name: 60ML ENFIT SYRINGE, STERILE
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: jessica walter ; three lakes drive; northfield, IL 60093
• MDR Report Key: 24203486
• Report Number: 1417592-2026-00072
• Device Sequence Number: 5534516
• Product Code: PNR
• UDI-Device Identifier: 10888277727304
• UDI-Public: 10888277727304
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K190502
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/28/2026

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
• Operator of Device: Lay User/Patient
• Device Catalogue Number: NON66160H
• Device Lot Number: 89724110001
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/03/2026
• Initial Report FDA Received Date: 01/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/01/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 10 YR
• Patient Sex: Female
• Patient Weight: 36 KG