MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; SYRINGE 5ML SALINE IN 10ML

Catalog Number	EMZE010055
Medical Device Problem Code	Unsealed Device Packaging (1444)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/04/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that posiflush we received have no plastic bag covering them therefore making them non-sterile.
Additional Manufacturer Narrative
The account reported finding no plastic bag covering item, and the complaint transcript stated that posiflush received had no plastic bag covering them, therefore making them non-sterile.A photo and a sample were received for the investigation; the customer provided a photo and 6ea syringes for review, and for both the syringes in the photo and the syringes returned, it appears that an improper fin seal occurred which caused an issue with the crimp seals on the overwraps.Based on the complaint details, photo and sample evaluation, and the investigation, the complaint is confirmed; the individual packaging for the syringes were not sealed, and the root cause appears to be a machine/automation process error during manufacturing.The sterility of the syringe is limited to the fluid pathway, and the non-sterile packaging is only protective; there has been no change to the reportability decision associated with this complaint.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: SYRINGE 5ML SALINE IN 10ML
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: diana arizmendi ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50868754
• Report Number: 1417592-2026-48747
• Device Sequence Number: 18810032
• Product Code: NGT
• UDI-Device Identifier: 00363807100558
• UDI-Public: 00363807100558
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K173348
• 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): 09/23/2026

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: EMZE010055
• Device Lot Number: 3145978
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 12/30/2025
• 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: 12/04/2025
• Initial Report FDA Received Date: 09/23/2026
• 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