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

Model Number DYND11218

Device Problem Deflation Problem (1149)

Patient Problem No Code Available (3191)

Event Date 01/22/2020

Event Type  malfunction  

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 Description

It was reported that the urinary catheter balloon was unable to be fully deflated.

• Brand Name: Medline
• Type of Device: CATHETER,FOLEY,COUDE,LATEX,18FR,10ML
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield, il
• Manufacturer Contact: nigel vilches ; three lakes drive; northfield, il ; 9311458
• MDR Report Key: 9705982
• MDR Text Key: 190761238
• Report Number: 1417592-2020-00013
• Device Sequence Number: 1
• Product Code: EZL
• UDI-Device Identifier: 10080196726776
• UDI-Public: 10080196726776
• 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,user faci
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 02/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DYND11218
• Device Catalogue Number: DYND11218H
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/10/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention
• Patient Age: 42 YR
• Patient Weight: 49