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

Catalog Number	MSG9065
Medical Device Problem Codes	Degraded (1153); Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/04/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "sensicare gloves for having ink on them, or transfer of the lot stamp on the top of the glove to the bottom of the glove (palm).I have also been getting complaints of the same gloves being stiff and breaking apart.".
Additional Manufacturer Narrative
The customer reported sensicare gloves "having ink on them, or transfer of the lot stamp on the top of the glove to the bottom of the glove (palm)" and complaints of the same gloves being "stiff and breaking apart." although a call tag was provided, no sample was provided; however, the reported issue of ink transfer/smearing on the surgical glove was confirmed via customer-supplied image.The complaint investigation regarding the gloves being "stiff and breaking apart" could not be completed because the reported product sample was not returned for evaluation and insufficient information was available to verify the alleged failure.Without physical examination of the product and/or additional supporting details, the reported condition cannot be confirmed, and the root cause of the reported issue remains unconfirmed.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,LF,PF,6.5
• 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: 50900314
• Report Number: 1417592-2026-51256
• Device Sequence Number: 5903765
• Product Code: KGO
• UDI-Device Identifier: 40888277347886
• UDI-Public: 40888277347886
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K193217
• 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): 09/24/2026

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: MSG9065
• Device Lot Number: 4032014565-3
• Was Device Available for Evaluation?: Yes
• 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: 12/04/2024
• Initial Report FDA Received Date: 09/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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