MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP; SCANNER, BLADDER, BIOCON 900, W/PRINTER

Catalog Number MDSB10900

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 08/13/2023

Event Type  Injury  

Manufacturer Narrative

According to the facility on (b)(6) 2023 the bladder scan "picked up 700ml and a foley catheter was placed per our algorithm, however only 200ml drained".Per the facility "the patient was bladder scanned again and it reported 700ml".Per the facility the device was calibrated by their biomed department prior to use and gel was used on the patient when performing the scan.Per the facility the patient was unable to void prior to the scan, but per their algorithm "if it would have given an accurate measurement less than 600ml they would have given the patient more time and not inserted a foley catheter right away".The device was requested for evaluation.No additional information is available at this time.It has been determined that the reported event could cause or contribute to serious injury if it were to occur.In an abundance of caution, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.

Event Description

According to the facility on (b)(6) 2023 the bladder scan "picked up 700ml and a foley catheter was placed per our algorithm, however only 200ml drained".

• Type of Device: SCANNER, BLADDER, BIOCON 900, W/PRINTER
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: justin herrmann ; three lakes drive; northfield, IL 60093
• MDR Report Key: 17689941
• MDR Text Key: 322720932
• Report Number: 1417592-2023-00362
• Device Sequence Number: 1
• Product Code: IYO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/06/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: MDSB10900
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/24/2023
• Date Manufacturer Received: 08/14/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other