MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; GLOVE,SURG, SENSICARE PI GRN,LF,PF,6.5

Catalog Number	MSG9265
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/28/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the customer is having tearing issues with item (b)(6).
Additional Manufacturer Narrative
The customer reported tearing issues with the surgical glove.Inspection reports were reviewed, the lot passed inspection for all physical properties per astm standards, and a historical complaint query for the last 12 months did not identify a trend.The sample was reviewed and there was tearing from the palm to the cuff, confirming the reported problem; only the torn sample was provided.The root cause was documented as "cannot determine cause w/received sample," and due to the lack of trend this was documented as an isolated event with continued trending and monitoring for quality assurance.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: GLOVE,SURG, SENSICARE PI GRN,LF,PF,6.5
• 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: 50914329
• Report Number: 1417592-2026-51869
• Device Sequence Number: 12104815
• Product Code: KGO
• UDI-Device Identifier: 30888277417148
• UDI-Public: 30888277417148
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K191915
• 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): 09/25/2026

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: MSG9265
• Device Lot Number: 2079053465-5
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/06/2023
• 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: 03/28/2023
• Initial Report FDA Received Date: 09/28/2026
• 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