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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC. 18FR SILICONE FOLEY CATHETER; EZL
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MEDLINE INDUSTRIES, INC. 18FR SILICONE FOLEY CATHETER; EZL Back to Search Results
Catalog Number DYND11503
Device Problem Break (1069)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/16/2014
Event Type  Injury  
Event Description
The cover to the inflation valve apparently broke and the catheter was replaced.
 
Manufacturer Narrative
The facility reported that in november during a robotic prostatectomy, the cover to the inflation valve broke.A second catheter was used.We inquired as to whether it could have been damaged during the procedure but no response was provided.We have not been made aware of any patient injury or that medical intervention was indicated.We have had no response to multiple attempts to obtain details pertaining to the incident.No other information was provided by the facility.The catheter was not retained for evaluation.No photos were sent.We have not confirmed the reported issue and a root cause has not been determined.
 
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Brand Name
18FR SILICONE FOLEY CATHETER
Type of Device
EZL
Manufacturer (Section D)
MEDLINE INDUSTRIES, INC.
mundelein IL 60060
Manufacturer Contact
julie finley
one medline place
mundelein, IL 60060
8476434709
MDR Report Key4356434
MDR Text Key5112212
Report Number1417592-2014-00121
Device Sequence Number1
Product Code EZL
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility
Reporter Occupation Nurse
Type of Report Initial
Report Date 12/15/2014
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 Operator Health Professional
Device Catalogue NumberDYND11503
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Event Location Hospital
Initial Date Manufacturer Received 11/21/2014
Initial Date FDA Received12/17/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other;
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