MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; DBD-SCANNER,BLADDER,BIOCON 700,W/PRINTER

Catalog Number	MDSB10700
Medical Device Problem Codes	Break (1069); Material Frayed (1262); Inadequate Lubrication (4057)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/20/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "the probe is shattered and needs oil, power cord is frayed.".
Additional Manufacturer Narrative
The customer stated, "the probe is shattered and needs oil, power cord is frayed." the investigation notification description states, "this complaint is being processed," and the record states, "no attachment documents available"; no device examination or test results are documented.Confirmation status and root cause were not identified in the provided investigation text, and the overall conclusion documented in the defect codes was "bladder scanner - servicing request." 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-SCANNER,BLADDER,BIOCON 700,W/PRINTER
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: venkata peruri ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50883746
• Report Number: 1417592-2026-49878
• Device Sequence Number: 9791904
• Product Code: IYO
• UDI-Device Identifier: 40884389154893
• UDI-Public: 40884389154893
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K091518
• 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: MDSB10700
• 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: 02/20/2023
• Initial Report FDA Received Date: 09/24/2026
• 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