MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC. Medline; CATHETER,FOLEY,COUDE,LATEX,18FR,10ML

Model Number	DYND11218
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	01/22/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that the urinary catheter balloon was unable to be fully deflated for removal.Reportedly, the patient was taken to a local hospital's emergency department (ed).An unspecified imaging exam was obtained and it was reportedly identified that the urinary catheter was in the patient's "prostate area" and that the patient experienced unspecified "tissue damage." it was unspecified if and/or how the urinary catheter was removed from the patient.The patient was reportedly admitted to the hospital for urosepsis and a suprapubic catheter was inserted in lieu of a urinary catheter.No additional information was available to be provided to the manufacturer.No sample was returned to the manufacturer for evaluation.A root cause was unable to be determined.Due to the reported need for hospital admission and medical intervention, this medwatch is being filed.If additional relevant information becomes available a supplemental medwatch will be filed.
Event or Problem Description
It was reported that the urinary catheter balloon was unable to be fully deflated.

• Brand Name: Medline
• Common Device Name: CATHETER,FOLEY,COUDE,LATEX,18FR,10ML
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield, il
• MDR Report Key: 9705982
• Report Number: 1417592-2020-00013
• Device Sequence Number: 19604685
• Product Code: EZL
• UDI-Device Identifier: 10080196726776
• UDI-Public: 10080196726776
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 02/13/2020

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: DYND11218
• Device Catalogue Number: DYND11218H
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/10/2020
• Initial Report FDA Received Date: 02/13/2020
• 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: Hospitalization; Other; Required Intervention
• Patient Age: 42 YR
• Patient Weight: 49