MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; GLOVE,EXAM,PF,NITRILE,SMARTBOX,S

Catalog Number	MDSXB7584
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Codes	Exposure to Body Fluids (1745); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/08/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "gloves are tearing" and "also some are out from the box before the patient use.".
Additional Manufacturer Narrative
According to the customer, gloves are "tearing" during patient care and are coming out of the box with tearing already present; the customer reported clinicians have come into contact with "blood" due to the reported incident, and when there is contact with blood the clinicians perform hand hygiene.Medline received one open box, pulled samples from the box and donned them, did not notice any tears in the gloves when they were removed from the box, was unable to replicate any tearing while donning, and also received three photos that show large tears in the gloves.The complaint was confirmed based on the images provided, although the reported issue was unable to be duplicated with samples.Pre-torn gloves are normally caused by the auto-stripping machine during manufacturing, and the overall conclusion was that the issue is confirmed.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,PF,NITRILE,SMARTBOX,S
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: veera karravula ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50913302
• Report Number: 1417592-2026-51794
• Device Sequence Number: 5778557
• Product Code: LZA
• UDI-Device Identifier: 20193489107750
• UDI-Public: 20193489107750
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K200960
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 09/25/2026

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: MDSXB7584
• Device Lot Number: CC309404322
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/14/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/08/2024
• Initial Report FDA Received Date: 09/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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