MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC. MEDLINE; 18FR 100% SIL CATH W/DRAIN BAG

Model Number	UROT1057
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/14/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported, "catheter breaking off after insertion." email received from sales representative, medline industries, inc., (b)(6), who provided the following the information as to what or how the foley catheter with drain bag broke after insertion; (b)(6) reports, "the seal that keeps the catheter and the line together failed and the catheter came off." no additional details are available related to the customer reported issue.Despite multiple good faith efforts to obtain additional information, the customer contact was unable or unwilling to provide further incident details to the manufacturer.The sample has been returned for testing and evaluation.Investigation conclusion / root cause: the reported issue of the catheter breaking off could not be confirmed through visual or functional evaluation of the received sample.Due to the reported incident, medical intervention and in an abundance of caution, this med watch is being filed.If any further relevant information is identified or obtained, a supplemental med watch will be submitted.
Event or Problem Description
It was reported; "catheter breaking off after insertion.".

• Brand Name: MEDLINE
• Common Device Name: 18FR 100% SIL CATH W/DRAIN BAG
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093 2753
• MDR Report Key: 12297583
• Report Number: 1417592-2021-00123
• Device Sequence Number: 4015011
• Product Code: OHR
• UDI-Device Identifier: 10193489604962
• UDI-Public: 10193489604962
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/09/2021

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
• Operator of Device: Health Professional
• Device Model Number: UROT1057
• Device Catalogue Number: UROT1057H
• Device Lot Number: 21BBD966
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/30/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/16/2021
• Initial Report FDA Received Date: 08/09/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention