MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; GLOVE,SURG,SENSICR PI ORTHO LT,LF,PF,7.0

Model Number	MSG9970
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/14/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "one pair of gloves (with the new exp date and same box/lot) rip at the finger tips.".
Additional Manufacturer Narrative
A complaint was received related to a "gloves rip at the fingertip" associated with the sensicare pi ortho lt surgical glove; the complaint transcript stated the issue did not occur during use and no injury occurred.No sample was available for further review, trending was performed over the last 2 years of complaints, the review of trending did not indicate that there is a trend of "tearing" or similar occurring in the field, and inspection for the lot was completed with passing results.The complaint was able to be confirmed via customer-supplied image, and the cause was documented as cannot determine cause.A review of the complaint information as well as the results of the investigation indicate no need for further action at this time.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,SENSICR PI ORTHO LT,LF,PF,7.0
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: zelek alexander ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50933237
• Report Number: 1417592-2026-53199
• Device Sequence Number: 10749727
• Product Code: KGO
• UDI-Device Identifier: 10193489029857
• UDI-Public: 10193489029857
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K142941
• 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 Model Number: MSG9970
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 10/21/2025
• 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: 10/14/2025
• Initial Report FDA Received Date: 09/29/2026
• 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