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

Catalog 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	07/16/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "over the past few months, we have noticed that they are tearing when being put on but in strange locations ¿ like as if the gloves had a seam".
Additional Manufacturer Narrative
A complaint was received related to "tearing when donning - but in strange locations, as if gloves had a seam" for the sensicare pi ortho surgical glove; there was no reported death or serious injury associated with this event.2 bx were returned, and when donning the gloves, tearing could not be confirmed/replicated, even as the gloves were elongated to elbow length; trending over the last 2 years did not indicate that there is a trend of "tearing during donning" or similar occurring in the field, and the vendor's review of batch records and retention samples observed no abnormalities or deviations.Complaint was unable to be confirmed via the returned sample.The updated cause code was adjusted to unconfirmed defect with not confirmed with received sample, and 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: nitish sandadi ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50719126
• Report Number: 1417592-2026-36307
• Device Sequence Number: 18656210
• Product Code: KGO
• UDI-Device Identifier: 10193489029857
• UDI-Public: 10193489029857
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): 09/07/2026

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: MSG9970
• Device Lot Number: 2109969270
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/04/2025
• 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: 07/16/2025
• Initial Report FDA Received Date: 09/10/2026
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown