MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; SET, BP, CUFF, BLD, PVC, 2T, LG ADL

Catalog Number	MDS91423
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	04/24/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the adult large (mds91423, lot: 65123110001) was put into service on 3/13/2024 and now has a hole in the bladder, requiring it to be taken out of service.
Additional Manufacturer Narrative
The customer reported that the adult large was put into service on 3/13/2024 and now has a hole in the bladder, requiring it to be taken out of service.Medline received one double tube inflation cuff in used condition and, upon visual inspection, confirmed that the cuff had a tear located where the tubing connects to the bladder, causing an air leak.The complaint was confirmed; per vendor, the complaint could not be confirmed based on dhr and inspection record review.Cause was documented as cannot determine cause with received sample, although the investigation stated the issue shown was most likely caused due to excessive bending around that area; this would prevent the cuff from inflating/deflating correctly, and the division will continue to monitor the issue for trending.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: SET, BP, CUFF, BLD, PVC, 2T, LG ADL
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: zelek alexander ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50755972
• Report Number: 1417592-2026-39501
• Device Sequence Number: 15763248
• Product Code: DXQ
• UDI-Device Identifier: 10080196717613
• UDI-Public: 10080196717613
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K211084
• 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): 09/10/2026

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: MDS91423
• Device Lot Number: 65123110001
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/07/2024
• 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: 04/24/2024
• 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): 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