MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; CUSHION,PRE-INFLATED,BUBBLE,BARI,28X22

Catalog Number	MSCBUB2822
Medical Device Problem Codes	Gas/Air Leak (2946); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/13/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that 5/6 have leaked from seams.Customer states he has tested cushions under water and has noticed where the air is leaking from.
Additional Manufacturer Narrative
The customer states he purchased bubble cushion (pck6), and 5/6 have leaked from seams; the customer tested cushions under water and noticed where the air is leaking from.Samples rec'd and complaint confirmed; the vendor completed the requested evaluation, found no potential cause for defect within their production records, and the supplier confirmed that the pressure test has been performed in accordance with standard requirements.The cause was documented as cannot determine cause w/received sample.There was no reported death or serious injury associated with this event, and the product was not used for treatment or diagnosis; a review of trending data indicates no negative trends associated with this defect or product code, and no further action is required at this time.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,BARI,28X22
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: aaron ginsburg ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50897864
• Report Number: 1417592-2026-50928
• Device Sequence Number: 10761937
• Product Code: KIC
• UDI-Device Identifier: 00193489086198
• UDI-Public: 00193489086198
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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: MSCBUB2822
• Device Lot Number: 33025090001
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/19/2026
• 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: 03/13/2026
• 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