MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; DBD-CUSTOM DRAPE AVAPREP

Catalog Number	SAMP0547
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/22/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that ¿qpl1286 custom laparotomy drape, the velcro tabs on the pouch are falling off.I observed it and it¿s happening frequently.¿.
Additional Manufacturer Narrative
The account reported finding velcro tabs falling off drape, and the velcro tabs on the pockets fall off with the slightest touch.A photo was received for the investigation; medline received two photos of the pack insert only, reviewed finished good production records, reviewed the finished good pack build, and reviewed trending with 0 additional reported complaint(s) for this issue for the account in the past 6 months.Medline was unable to confirm the reported defect as there was no samples or detailed pictures received for this complaint investigation.Without a sample it is difficult to determine a true root cause for the reported issue, 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-CUSTOM DRAPE AVAPREP
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: donovan frazier ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50853285
• Report Number: 1417592-2026-47330
• Device Sequence Number: 9936591
• Product Code: PUI
• UDI-Device Identifier: 40195327267699
• UDI-Public: 40195327267699
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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): 09/21/2026

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: SAMP0547
• Device Lot Number: 22JBM051
• 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: 02/22/2023
• Initial Report FDA Received Date: 09/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown