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

Catalog Number	FG2603
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
This vmsr report summarizes 2 malfunction events that occurred between july 1 and september 30, 2025.The account reported that nitrile exam gloves (fg2503) were tearing during use.No patient information was available.No patient or user injuries were reported.
Additional Manufacturer Narrative
"this vmsr submission is part of a retrospective data remediation review.The included events represent 2 malfunction events that medline became aware of during july 1 and september 30, 2025.Associated lot numbers an411885143 and koe503243576.A complaint was received regarding fg2503 nitrile exam gloves following reports that gloves were tearing during use.The account reported that 178 cases of product associated with lot numbers an411885143 and koe503243576 were removed from inventory due to the reported condition and requested return and replacement of the affected product.Samples were reportedly returned; however, despite delivery confirmation, the samples could not be located and were therefore unavailable for evaluation.The vendor was notified and conducted an investigation using batch records and retained samples for the reported lots.The vendor reported that no abnormalities were identified during review of manufacturing records or retained product samples.Trending analysis was performed for the vendor, reported defect type, and product family, and no adverse trend associated with tearing or similar complaints was identified.Inspection record (b)(4) was reviewed and documented passing results for the reported lot.Based on the available information, the reported issue could not be confirmed and a definitive root cause could not be determined.The complaint will continue to be monitored through routine trend analysis.Samples were not available for evaluation.The devices were labeled for single use.No devices were identified as reprocessed or reused.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,SELECT,TXT FNGR,L
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: nitish sandadi ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50818999
• Report Number: 1417592-2026-44697
• Device Sequence Number: 13431211
• Product Code: LZA
• UDI-Device Identifier: 10888277170933
• UDI-Public: 10888277170933
• Combination Product (Y/N): N
• Initial Reporter State: DE
• Initial Reporter Country: US
• Exemption Number: VMSR
• Number of Events Summarized: 2
• Summary Report (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Type of Report: Initial
• Report Date (Section B): 09/16/2026

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: FG2603
• 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: 09/24/2025
• Initial Report FDA Received Date: 09/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Patient Sex: Unknown