MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; GLOVE,SURG, SENSICARE PI GRN,LF,PF,7.0

Catalog Number	MSG9270
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "we had another glove rip.".
Additional Manufacturer Narrative
The complaint was received related to a "ripped" sensicare pi green surgical glove; the customer reported, "we had another glove rip," and there was no reported death or serious injury associated with this event.Medline observed tearing on the returned glove, performed trending over the last 2 years of complaints, confirmed the lot inspection was completed with passing results, and the vendor's review of batch records and retention samples found no abnormalities or deviations.Based on the sample returned, medline was able to confirm the complaint issue or that the product failed to meet specifications; the cause was recorded as "cannot determine cause w/received sample." no trending was identified at this time, the investigation indicated no need for further action, and complaints are monitored via the trend analysis procedure.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,7.0
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: ankitha komirishetty ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50872249
• Report Number: 1417592-2026-49274
• Device Sequence Number: 9224144
• Product Code: KGO
• UDI-Device Identifier: 10888277417151
• UDI-Public: 10888277417151
• 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): 09/23/2026

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: MSG9270
• Device Lot Number: 4097724070-1
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/09/2025
• 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: 05/01/2025
• Initial Report FDA Received Date: 09/23/2026
• 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