MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; CUSHION,PRE-INFLATED,BUBBLE,18X18

Catalog Number	MSCBUB1818
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/06/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "i've seen 3 almost flat air cushions over the last couple of weeks.".
Additional Manufacturer Narrative
Customer reported, "i've seen 3 almost flat air cushions over the last couple of weeks," and no injury was reported.Samples were returned; medline was not able to find any holes or tears in the seams, sent photos to the qe in asia, and requested review of the production record and inspection records with the vendor.The quality defect was confirmed as reported, and it was determined that the maintenance frequency for the molds is too low, and long term withstand voltage tests, pressure is too low.The vendor changed the procedure of maintenance frequency of the mold to once a month and will increase the pressure to 200 kilograms/6 columns; complaint trending for the last 6 months was reviewed and this is not a trending issue as the quality rate is <0.2% of product sold.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: CUSHION,PRE-INFLATED,BUBBLE,18X18
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: veera karravula ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50886178
• Report Number: 1417592-2026-50285
• Device Sequence Number: 13218041
• Product Code: KIC
• UDI-Device Identifier: 20888277723723
• UDI-Public: 20888277723723
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 09/23/2026

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: MSCBUB1818
• Device Lot Number: 33023070001
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/27/2024
• 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: 03/06/2024
• Initial Report FDA Received Date: 09/24/2026
• 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