MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; SOLUTION,WATER,IRRIGATION,250ML,STRL

Catalog Number	PCS1550
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/24/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "after looking at the product it has been discovered that it is not mold, it is a string (foreign object).".
Additional Manufacturer Narrative
The customer reported mold found in sterile water and later stated that, after looking at the product, "it has been discovered that it is not mold, it is a string (foreign object)." medline quality visually inspected the samples and found 30 were fully sealed and one sample was open; there appears to be a string, yellow/green in color and approximately 1" in length, floating inside the bottle, and all remaining bottles appeared unaffected.As a result, medline confirmed the reported complaint.Per the vendor, the root cause of the string in the bottle could possibly be from a production technician's clothing; the division will monitor the complaint during quarterly trending.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: SOLUTION,WATER,IRRIGATION,250ML,STRL
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: narendra nambula ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50854774
• Report Number: 1417592-2026-47581
• Device Sequence Number: 9923493
• Product Code: FRO
• UDI-Device Identifier: 40080196427056
• UDI-Public: 40080196427056
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K083042
• 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: PCS1550
• Device Lot Number: 22073714
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 01/31/2023
• 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: 01/24/2023
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown