MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; GLOVE,EXAM,NITRILE,SENSICARE-ICE,BLUE,SM

Catalog Number	MDS2501
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/20/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the gloves are ripping at cuffs and forefinger and thumbs.
Additional Manufacturer Narrative
The customer stated gloves are ripping at cuffs and forefinger and thumbs, with 5 rips in one morning and more throughout the month.Inspection reports were reviewed, 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; no physical sample was available; however images confirmed the complaint.The device history record for this shipment was reviewed, the shipment fulfilled quality requirement and passed within aql level for all criteria at in house qa inspection, and the retention sample was inspected with 100% check with no abnormality.Based on the investigation from the defect photos, the probable cause was a knocking defect caused by the faulty or loose former holder, and corrective action was to revise monthly preventive maintenance to include holder guide inspection.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,SENSICARE-ICE,BLUE,SM
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: ayan asim ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50903964
• Report Number: 1417592-2026-51489
• Device Sequence Number: 5903844
• Product Code: LZA
• UDI-Device Identifier: 40884389186245
• UDI-Public: 40884389186245
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K211220
• 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): 09/25/2026

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: MDS2501
• Device Lot Number: KOE207151558
• 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: 11/20/2023
• Initial Report FDA Received Date: 09/25/2026
• 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