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

Catalog Number	MSG6365
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	Exposure to Body Fluids (1745)
Date of Event	02/17/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
According to the facility, during completion of a picc insertion, staff removed sterile gloves and observed blood on the staff member¿s thumb; the staff member reported no skin tears or breakdown and did not feel a needlestick injury during the procedure.Inspection records for the reported sku lot were reviewed and the lot passed with no abnormalities noted; no photo or sample was received, and picture/sample evaluation was n/a.As a result, medline was unable to confirm the presence of a defect during this investigation.The root cause could not be determined in the absence of a physical sample, and the quality team will continue to monitor for trending.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.
Event or Problem Description
It was reported that "the concern is that the glove ripped during the procedure.".

• Brand Name: MEDLINE
• Common Device Name: GLOVE,SURG,SENSICARE NEOPRENE,LF,PF,6.5
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: raveena sampathi ; three lakes drive; northfield, IL
• MDR Report Key: 50548806
• Report Number: 1417592-2026-29849
• Device Sequence Number: 10311964
• Product Code: KGO
• UDI-Device Identifier: 10193489000030
• UDI-Public: 10193489000030
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K192820
• 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): 08/31/2026

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: MSG6365
• Device Lot Number: 5082943665-2
• Was Device Available for Evaluation?: No
• 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: 02/17/2026
• Initial Report FDA Received Date: 09/01/2026
• 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