MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; GLOVE,SURG,SENSICARE NEOPRENE,LF,PF,8.0

Catalog Number	MSG6380
Medical Device Problem Codes	Material Puncture/Hole (1504); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/19/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer reported that they have opened 2 of the boxes of gloves so far and both have had gloves with holes in them.A historical complaint query was performed for the last 12 months, a trend has not been identified, and due to the lack of lot number medline was unable to verify which lot this item belongs to; the customer was contacted and medline was informed that she no longer has the sample nor the lot number.The image shows the hole/tear on the gloves, and based on the images medline was able to confirm the complaint.Due to lack of lot number, medline was unable to send this to the vendor for further root cause analysis; pre-torn gloves are normally caused by the auto-stripping machine during manufacturing, and sometimes torn gloves are missed during inspection and accidently packed into boxes.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.
Event or Problem Description
It was reported that "they have opened 2 of the boxes of gloves so far and both have had gloves with holes in them.".

• Brand Name: MEDLINE
• Common Device Name: GLOVE,SURG,SENSICARE NEOPRENE,LF,PF,8.0
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: zelek alexander ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50915556
• Report Number: 1417592-2026-52018
• Device Sequence Number: 5394060
• Product Code: KGO
• UDI-Device Identifier: 30193489000065
• UDI-Public: 30193489000065
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K192820
• 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: MSG6380
• 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: 01/19/2023
• Initial Report FDA Received Date: 09/28/2026
• 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