MAUDE Adverse Event Report: Medline Industries LP Medline; MDSALINE7

Catalog Number	MDSALINE7
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	07/17/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Customer reported an infection.
Additional Manufacturer Narrative
The customer reported an infection.No additional information is available at this time.It has been determined that the reported event caused or contributed to a serious injury.Based on the information reviewed, this is a reportable event as defined under 21 cfr 803.3.

• Brand Name: Medline
• Common Device Name: MDSALINE7
• Manufacturer (Section D): Medline Industries LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: kelly zampella ; three lakes drive; northfield, IL 60093
• MDR Report Key: 50160971
• Report Number: 1417592-2026-08331
• Device Sequence Number: 9103067
• Product Code: FRO
• UDI-Device Identifier: 10193489089356
• UDI-Public: 10193489089356
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 08/06/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: MDSALINE7
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/17/2026
• Initial Report FDA Received Date: 08/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown