MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP Medline; 16FR10ML 100%SIL UM 1LYR CNTRN

Model Number	UROT1048
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/08/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Catheter fell out requiring replacement.
Additional Manufacturer Narrative
According to the customer contact, on (b)(6) 2023 "a foley was placed in the patient.Patient was put prone and the foley fell out.Upon inspection there was a large hole in the balloon.A different foley was retrieved and placed in the patient".Customer reports the patient is doing "fine" and there was no additional medical intervention reported related to the incident.A sample was returned for evaluation.It has been determined that the reported event could cause or contributed to serious injury, therefore, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.

• Brand Name: Medline
• Common Device Name: 16FR10ML 100%SIL UM 1LYR CNTRN
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: kelly zampella ; three lakes drive; northfield, IL 60093
• MDR Report Key: 16682397
• Report Number: 1417592-2023-00152
• Device Sequence Number: 7989221
• Product Code: OHR
• UDI-Device Identifier: 10888277775848
• UDI-Public: 10888277775848
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: UROT1048
• Device Catalogue Number: UROT1048
• Device Lot Number: 22LBP414
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/20/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/09/2023
• Initial Report FDA Received Date: 04/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown