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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTERSURGICAL LIMITED GUERNSEY FLEXIBLE CATHETER MOUNT
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INTERSURGICAL LIMITED GUERNSEY FLEXIBLE CATHETER MOUNT Back to Search Results
Model Number 3511000
Device Problem Leak/Splash (1354)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/12/2020
Event Type  Injury  
Manufacturer Narrative
The complaint sample is enroute and will be evaluated upon receipt.We will provide follow up report upon completion of our evaluation.There is no report of harm to patient.
 
Event Description
Info was then received as follows: "the leakage was noticed whilst the patient was attached due to vent alarm of leakage, the catheter mount was changed to a new one and the same was happening - it was the 4th catheter mount that was eventually found not to be leaking.So 3 faulty ones already, we have a box remaining in the house of them.The faulty ones that have been identified so far have been kept to the side.No harm came to the patient.".
 
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Brand Name
FLEXIBLE CATHETER MOUNT
Type of Device
FLEXIBLE CATHETER MOUNT
Manufacturer (Section D)
INTERSURGICAL LIMITED GUERNSEY
circuit house, pitronnerie rd
st. peter port, guernsey channel islands GY12R L
UK  GY12RL
MDR Report Key10453750
MDR Text Key204552439
Report Number1319447-2020-00005
Device Sequence Number1
Product Code BZA
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign
Type of Report Initial
Report Date 08/19/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/26/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator No Information
Device Model Number3511000
Device Lot Number2180765
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? No
Device Age1 YR
Event Location Home
Was Device Evaluated by Manufacturer? Yes
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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