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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: UNOMEDICAL A/S I PORT ADVANCE; I-PORT ADVANCE 9 MM
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UNOMEDICAL A/S I PORT ADVANCE; I-PORT ADVANCE 9 MM Back to Search Results
Model Number MMT-101
Medical Device Problem Code Device Handling Problem (3265)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 05/07/2024
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
(b)(6).
 
Event or Problem Description
Unomedical reference number (b)(4).Event occurred in united kingdom.On (b)(6) 2024, it was reported that infusion set canula was not inserted properly.No further information available.
 
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Brand Name
I PORT ADVANCE
Common Device Name
I-PORT ADVANCE 9 MM
Manufacturer (Section D)
UNOMEDICAL A/S
aaholmvej 1-3
osted
lejre, 4320
DA  4320
Manufacturer Contact
aaholmvej 1-3
osted
lejre, 4320
MDR Report Key19491430
Report Number3003442380-2024-07172
Device Sequence Number17918968
Product Code FOZ
UDI-Device Identifier05705244009417
UDI-Public05705244009417
Combination Product (Y/N)N
Initial Reporter StateCA
Initial Reporter CountryUS
PMA/510(K) Number
K120337
Number of Events Summarized1
Summary Report (Y/N)N
Serviced by Third Party (Y/N)N
Reporter Type Manufacturer
Report Source Distributor
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 06/07/2024
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 Lay User/Patient
Device Model NumberMMT-101
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 05/08/2024
Initial Report FDA Received Date06/07/2024
Was Device Evaluated by Manufacturer? (Y/N) No
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 Unknown
Patient Sequence Number1
Patient SexUnknown
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