MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; GLOVE,EXAM,NITRILE,PF,2CT INR,100CT,OSFM

Catalog Number	CUR4145RH
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/23/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "the nitrile quality is too thin.It immediately leaks and has been repetitively tearing when fitted on hands" and "the quality of material allows moisture to penetrate through or when putting them on my small to medium size hands they tear at the wrist.".
Additional Manufacturer Narrative
The customer reported that the nitrile quality is too thin, immediately leaks, has been repetitively tearing when fitted on hands, allows moisture to penetrate through, and tears at the wrist when putting them on small to medium size hands.Inspection reports were reviewed, and the lot passed inspection for all physical properties per astm standards; a historical complaint query was performed for the last 12 months, and a trend has not been identified.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,NITRILE,PF,2CT INR,100CT,OSFM
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: arthem smalyukh ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50950426
• Report Number: 1417592-2026-54807
• Device Sequence Number: 10348815
• Product Code: LZA
• UDI-Device Identifier: 00884389108409
• UDI-Public: 00884389108409
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K051378
• 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): 09/29/2026

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: CUR4145RH
• Device Lot Number: AN208250178
• 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: 03/23/2023
• Initial Report FDA Received Date: 09/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown