MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP-NAMIC; SYRINGE,10ML,PP/FG,RA,-,PKG

Catalog Number	70095107
Medical Device Problem Codes	Loose or Intermittent Connection (1371); Connection Problem (2900)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/29/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
According to the facility, "syringe swivels and they are loosing medication." 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 1417592 on 22-jan-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
According to the facility, "syringe swivels and they are losing medication".
Additional Manufacturer Narrative
Updated d4: expiration date and h4: manufacturing date.
Additional Manufacturer Narrative
Updated g6, e1, added additional contact information.

• Common Device Name: SYRINGE,10ML,PP/FG,RA,-,PKG
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP-NAMIC; 10 glens falls technical park; glens falls NY 12801 3864
• Manufacturer Contact: kelly zampella ; three lakes drive; northfield, IL 60093
• MDR Report Key: 22898249
• Report Number: 3015910259-2025-00061
• Device Sequence Number: 5986865
• Product Code: OEQ
• UDI-Device Identifier: 10193489066043
• UDI-Public: 10193489066043
• Combination Product (Y/N): N
• Initial Reporter State: WV
• Initial Reporter Country: US
• 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,Followup,Followup
• Report Date (Section B): 03/13/2026

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: 70095107
• Device Lot Number: 0000132001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/29/2025
• Supplement Date Received by Manufacturer: 08/27/2025; 02/18/2026
• Initial Report FDA Received Date: 08/26/2025
• Supplement Report FDA Received Date: 09/10/2025; 03/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/24/2024
• 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 Sex: Unknown