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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HYDROMID; CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
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HYDROMID; CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS Back to Search Results
Model Number MID-141
Medical Device Problem Code Infusion or Flow Problem (2964)
Health Effect - Clinical Code Insufficient Information (4580)
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
A review of the device history record for the affected lot, and its associated subassemblies was performed; this review did not reveal any anomalies, deviations, or nonconformances.Lot release testing results for the finished good lot were reviewed, and also did not reveal any anomalies or deviations; all results met the product spec requirements.
 
Event or Problem Description
The clinician reported that the hydromid catheter had occluded the day after it was implanted.
 
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Brand Name
HYDROMID
Common Device Name
CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
MDR Report Key12366665
Report Number3015060232-2021-00003
Device Sequence Number3503594
Product Code FOZ
UDI-Device Identifier00862559000449
UDI-Public(01)00862559000449(17)220531(10)06072103
Combination Product (Y/N)N
Initial Reporter StateFL
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Serviced by Third Party (Y/N)N
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Nurse
Type of Report Initial
Report Date (Section B) 08/25/2021
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
Operator of Device Health Professional
Device Expiration Date05/31/2022
Device Model NumberMID-141
Device Catalogue NumberMID-141
Device Lot Number06072103
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 08/17/2021
Initial Report FDA Received Date08/25/2021
Was Device Evaluated by Manufacturer? (Y/N) Device Not Returned to Manufacturer
Date Device Manufactured06/07/2021
Is the Device Labeled for Single Use? (Y/N) Yes
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Usage of Device Initial
Patient Sequence Number1
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