MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; GLOVE,SURG,ADVANTAGE PI UNDRGLV,LF,PF,6

Catalog Number	AVT0260
Medical Device Problem Codes	Material Fragmentation (1261); Material Separation (1562); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/01/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that product tears when donning gloves, and the product was flaking off during use.The portion of shredded surgical glove fell into patient's mediastinum.The surgeon noticed at 1106 but unaware of when glove became contaminated and whose glove had a hole in it.The surgeon, medical student and first assist removed and replaced gloves.The wound class changed to contaminated from break in sterile technique.What was the original intended procedure? cabg (coronary artery bypass graft), coronary artery bypass grafting times, left internal mammary artery takedown, endoscopic left saphenous vein harvesting; transesophageal echocardiogram; cystoscopy, foley placement by urology service,.
Additional Manufacturer Narrative
It was reported that product tears when donning gloves, and the product was flaking off during use.The portion of shredded surgical glove fell into patient's mediastinum.The surgeon noticed at 1106 but unaware of when glove became contaminated and whose glove had a hole in it.The surgeon, medical student and first assist removed and replaced gloves.The wound class changed to contaminated from break in sterile technique.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.

• Brand Name: MEDLINE
• Common Device Name: GLOVE,SURG,ADVANTAGE PI UNDRGLV,LF,PF,6
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: meghana maddilli ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50713480
• Report Number: 1417592-2026-09726
• Device Sequence Number: 21333444
• Product Code: KGO
• UDI-Device Identifier: 10197344099689
• UDI-Public: 10197344099689
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: K191915
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 09/10/2026

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: Health Professional
• Device Catalogue Number: AVT0260
• Device Lot Number: 5098787360
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/26/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/18/2026
• Initial Report FDA Received Date: 09/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/01/2025
• 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
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 74 YR
• Patient Sex: Male
• Patient Weight: 200 LB
• Patient Race: White