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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. TRANSPAC® IV MONITORING KIT, DISPOSABLE TRANSDUCER, 03 ML SQUEEZE FLUSH, MACRODR; TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR
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ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. TRANSPAC® IV MONITORING KIT, DISPOSABLE TRANSDUCER, 03 ML SQUEEZE FLUSH, MACRODR; TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR Back to Search Results
Catalog Number 01C-42584-05
Device Problem Infusion or Flow Problem (2964)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/01/2020
Event Type  malfunction  
Manufacturer Narrative
It is unknown if the sample is available for investigation.
 
Event Description
The event occurred on an unknown date and involves a transpac iv monitoring kit, disposable transducer, 03 ml squeeze flush, macrodrip that the customer reported air leakage.No more information was provided.
 
Manufacturer Narrative
H10: no product samples, pictures, or videos were received for investigation.Therefore, a comprehensive failure investigation cannot be performed and a cause cannot be determined.A manufacturing record review could not be completed as the lot number was not provided by the customer.
 
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Brand Name
TRANSPAC® IV MONITORING KIT, DISPOSABLE TRANSDUCER, 03 ML SQUEEZE FLUSH, MACRODR
Type of Device
TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR
Manufacturer (Section D)
ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.
avenida cuarzo no. 250
ensenada, b.cfa. 22790
MX  22790
MDR Report Key9659013
MDR Text Key204604407
Report Number9617594-2020-00031
Device Sequence Number1
Product Code DRS
Combination Product (y/n)N
PMA/PMN Number
K061573
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 01/14/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/03/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number01C-42584-05
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Date Manufacturer Received02/20/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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