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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; TRAY,FOLEY,100% SILICONE,16FR,10ML,LF

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MEDLINE INDUSTRIES INC.; TRAY,FOLEY,100% SILICONE,16FR,10ML,LF Back to Search Results
Catalog Number DYND11519
Device Problem Inflation Problem (1310)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/01/2019
Event Type  malfunction  
Manufacturer Narrative
It was reported that after being inserted into the patient, the urinary catheter balloon would not inflate.According to the reporting facility, the urinary catheter balloon was not pre-inflated prior to being inserted into the patient.When the reported product issue was identified, the urinary catheter was removed and a new urinary catheter was inserted.No further incident or adverse patient impact was reported to the manufacturer.The urinary catheter involved in this incident was discarded and unavailable to be returned to the manufacturer for evaluation.A root cause for the reported incident was unable to be determined.Due to the reported need for medical intervention to remove and replace the urinary catheter, this medwatch is being filed.If additional relevant information becomes available a supplemental medwatch will be filed.
 
Event Description
It was reported that after being inserted into the patient, the urinary catheter balloon would not inflate.
 
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Type of Device
TRAY,FOLEY,100% SILICONE,16FR,10ML,LF
Manufacturer (Section D)
MEDLINE INDUSTRIES INC.
three lakes drive
northfield IL 60093 2753
Manufacturer Contact
nigel vilches
three lakes drive
northfield, IL 60093-2753
2249311458
MDR Report Key9440235
MDR Text Key190773395
Report Number1417592-2019-00226
Device Sequence Number1
Product Code OHR
UDI-Device Identifier10080196809790
UDI-Public10080196809790
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 faci
Reporter Occupation Other
Type of Report Initial
Report Date 12/09/2019
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
Device Operator Health Professional
Device Catalogue NumberDYND11519
Device Lot Number96919040002
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 12/06/2019
Initial Date FDA Received12/09/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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