MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; GLOVE,EXAM,NITRL,PF,TXT FNGR,S

Catalog Number	FG2501
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/09/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "sudden and dramatic increase instances of gloves tearing or ripping open and exposing users¿ skin during patient care activities.".
Additional Manufacturer Narrative
The reporter described gloves "tearing or ripping open" and "exposing users skin" during patient care activities, with "rips and tears" occurring every shift.A historical complaint query was performed for the last 12 months, and "a trend has not been identified"; "no lot or images have been provided," and due to lack of lot number medline was unable to decipher the vendor because the item is multisourced.The reported problem was unconfirmed, with the cause documented as "sample required to determine cause." medline stated it will continue to trend and monitor this item for continued quality assurance, and there was no change to the reportability decision associated with this complaint.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,EXAM,NITRL,PF,TXT FNGR,S
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: narendra nambula ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50852418
• Report Number: 1417592-2026-47239
• Device Sequence Number: 21320434
• Product Code: LZA
• UDI-Device Identifier: 40888277170903
• UDI-Public: 40888277170903
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K171339
• 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): 09/17/2026

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: FG2501
• 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: 04/24/2023
• Initial Report FDA Received Date: 09/22/2026
• 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