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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC TRAY CATH 400ML UM SLIDE TAP 14F SILICONE FOLEY SAFESECURE; KIT, URINARY DRAINAGE COLLECTION
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MEDLINE INDUSTRIES INC TRAY CATH 400ML UM SLIDE TAP 14F SILICONE FOLEY SAFESECURE; KIT, URINARY DRAINAGE COLLECTION Back to Search Results
Catalog Number UROT1070
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Injury (2348); Hematuria (2558)
Event Date 01/15/2020
Event Type  Injury  
Event Description
This facility saw multiple patients with injury related to the 14fr medline catheter.Post insertion attempts patients developed different symptoms from hematuria, false passages, urethra trauma.These patients required cystoscopies due to the trauma/injury.Some required a foley post discharge from the medical center.Manufacturer response for tray cath 400ml um with slide tap 14fr silicone foley safesecure custom, (brand not provided) (per site reporter).Medline's response was that they had not seen these issues at other facilities.We are returning unused product to medline.
 
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Brand Name
TRAY CATH 400ML UM SLIDE TAP 14F SILICONE FOLEY SAFESECURE
Type of Device
KIT, URINARY DRAINAGE COLLECTION
Manufacturer (Section D)
MEDLINE INDUSTRIES INC
1 medline place
mundelein IL 60060
MDR Report Key9853356
MDR Text Key184086217
Report Number9853356
Device Sequence Number1
Product Code PPG
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 01/29/2020,01/28/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberUROT1070
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA01/29/2020
Event Location Hospital
Date Report to Manufacturer03/19/2020
Initial Date Manufacturer Received Not provided
Initial Date FDA Received03/19/2020
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Other; Required Intervention;
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