MAUDE Adverse Event Report: Medline Industries, LP MEDLINE CO-LABEL; SCANNER,BLADDER,BIOCON 750,W/PRINTER

Catalog Number	MDSB10750
Medical Device Problem Codes	Incorrect, Inadequate or Imprecise Result or Readings (1535); Calibration Problem (2890)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/10/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "it read incorrectly 0ml patient had 500ml" and the customer was "having accuracy reading issues as well as issues passing the cal kit" and "getting the error messages "ec10, ec15.".
Additional Manufacturer Narrative
The customer reported "accuracy reading issues," "issues passing the cal kit," error messages "ec10, ec15," and stated, "it read incorrectly 0ml patient had 500ml." the investigation details state that the complaint was being processed, and no product evaluation or examination results were documented.The reported problem was unconfirmed, and the cause code was changed to "unconfirmed - servicing request." no root cause was identified; the complaint was closed with defect code "bladder scanner - servicing request" and corrective action type "none." 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 CO-LABEL
• Common Device Name: SCANNER,BLADDER,BIOCON 750,W/PRINTER
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: sangameswaran saravanakumar ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50866679
• Report Number: 1417592-2026-48484
• Device Sequence Number: 21188490
• Product Code: ITX
• UDI-Device Identifier: 40884389154893
• UDI-Public: 40884389154893
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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: MDSB10750
• 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: 03/10/2023
• Initial Report FDA Received Date: 09/23/2026
• Was Device Evaluated by Manufacturer? (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