MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; DBD-C SECTION PACK

Catalog Number	DYNJHTCS06
Medical Device Problem Code	Lack of Effect (4065)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/17/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "gown lvl3 in this c-section pack was not impervious - when took off gown - blood had gotten through sleeves and nurse's arms were covered in blood.".
Additional Manufacturer Narrative
According to the facility, staff members experienced strikethrough on their arms during a procedure; per the facility there was no impact to the staff member or patient, and no medical intervention, serious injury, or follow-up care was reported.A sample was received for investigation, three unused packs with three spt-2362p gowns were evaluated, finished good production records and finished good pack build were reviewed, and trending was reviewed.No damage or defect with the gown was observed; the gown has an aami level 3 rating, is fluid resistant but will not prevent strikethrough, and the item performed to specifications.The cause code was adjusted to dc: traced to user with knowledge, and the supplier quality team will monitor this issue for trending purposes.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-C SECTION PACK
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: rizwan shaik ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50755570
• Report Number: 1417592-2026-39436
• Device Sequence Number: 15753842
• Product Code: OHM
• UDI-Device Identifier: 40888277079060
• UDI-Public: 40888277079060
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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): 09/09/2026

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: DYNJHTCS06
• Device Lot Number: 23IBE271
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 11/21/2023
• 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: 11/17/2023
• Initial Report FDA Received Date: 09/14/2026
• 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