MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; DBD-GOWN,POLYRNF,BRTHSLV,XL,100/CS

Catalog Number	SPT-2208CS
Medical Device Problem Code	Nonstandard Device (1420)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/09/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "their technician who is cleaning scopes in the scope room has complained of getting wet through the gown"; "specifically, it¿s the seam on the sleeves"; "she¿s getting wet on the sleeves"; "she is not getting wet on the trunk.".
Additional Manufacturer Narrative
The customer reported that the technician cleaning scopes in the scope room complained of getting wet through the gown, specifically at the seam on the sleeves, and was not getting wet on the trunk.Medline received samples and reviewed them with the division; the samples were reviewed and the wrong material was used on the arms of the gowns.The reported problem was confirmed.This was identified as a manufacturing issue, with cause listed as mfg: assembly/human error, and a stock check was initiated, product was put on hold, a recall was issued, and a scar was issued to the vendor.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: DBD-GOWN,POLYRNF,BRTHSLV,XL,100/CS
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: raveena sampathi ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50897371
• Report Number: 1417592-2026-50842
• Device Sequence Number: 10761923
• Product Code: FYA
• UDI-Device Identifier: 40080196029755
• UDI-Public: 40080196029755
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K964142
• 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: SPT-2208CS
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 10/17/2023
• 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: 10/09/2023
• Initial Report FDA Received Date: 09/25/2026
• 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