MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; ERASE BSI IJ DRESSING CHANGE KIT

Catalog Number	BSIIJ1000
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/08/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that: hole in right glove.
Additional Manufacturer Narrative
The account reported finding holes n glove w burn marks.A photo and a sample were received for investigation; production records found no nonconformances noted by production or quality control personnel during first article, in-process, or case packaging inspections, and sample evaluation found a hole was visible in one of the fingers of the glove.The reported issue was confirmed.The vendor stated that the most probable cause might have been due to foreign particles on the surface of the former which was not removed in the washing tank, causing deposit in the glove; centurion's complaint history and production data over the past five years were reviewed with no other reports of a hole in the glove identified, and the issue appears to be isolated.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: ERASE BSI IJ DRESSING CHANGE KIT
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: narendra nambula ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50896818
• Report Number: 1417592-2026-50762
• Device Sequence Number: 13433173
• Product Code: OXQ
• UDI-Device Identifier: 40889942344643
• UDI-Public: 40889942344643
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• 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): 09/24/2026

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: BSIIJ1000
• Device Lot Number: 2023083190
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/09/2024
• 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: 02/08/2024
• Initial Report FDA Received Date: 09/25/2026
• Was Device Evaluated by Manufacturer? (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