MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; GLOVE,SURG, SENSICARE PI MICRO,LF,PF,6.0

Catalog Number	MSG9660
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/22/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "gloves that have been ripping.".
Additional Manufacturer Narrative
The complaint was logged for the issue of "ripping" with sensicare pi micro surgical gloves.Although a fedex call tag was provided, no sample nor image was returned for review; from the vendor's review of their batch records and retention samples, no abnormalities or deviations were observed.Without the sample to evaluate, the complaint could not be confirmed and a potential root cause could not be identified.No further investigation into the cause and complaint is warranted, and complaints are monitored via the sop-00032 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 MICRO,LF,PF,6.0
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: sasidhar lakku ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50714928
• Report Number: 1417592-2026-35750
• Device Sequence Number: 21482455
• Product Code: KGO
• UDI-Device Identifier: 30888277417285
• UDI-Public: 30888277417285
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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): 09/07/2026

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: MSG9660
• Device Lot Number: 4032014760
• 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: 10/22/2024
• Initial Report FDA Received Date: 09/10/2026
• 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