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	08/15/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "these gloves ripped today msg9265 when scrubber audra was donning gloves.".
Additional Manufacturer Narrative
A complaint was received related to a "tearing when donning" associated with the sensicare pi surgical glove, and the complaint transcript reported "ripping when scrubber audra was donning gloves." a sample and image were provided with the torn cuff, trending was performed over the last 2 years of complaints, the lot inspection was completed with passing results, and the vendor's review of batch records and retention samples found no abnormalities or deviations.The complaint was able to be confirmed via the returned sample, but no root cause could be determined.No adverse trending was identified at this time, and the review indicated no need for further action.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: pranay abbu ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50913403
• Report Number: 1417592-2026-51801
• Device Sequence Number: 5344761
• Product Code: KGO
• UDI-Device Identifier: 10888277417144
• UDI-Public: 10888277417144
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 09/28/2026

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: 5032257065-3
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/20/2025
• 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: 08/15/2025
• 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