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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. MICROCLAVE NEUTRAL CONNECTOR; SET, ADMINISTRATION, INTRAVASCULAR
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ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. MICROCLAVE NEUTRAL CONNECTOR; SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number B3300
Device Problem Backflow (1064)
Patient Problems No Consequences Or Impact To Patient (2199); Blood Loss (2597)
Event Date 09/29/2020
Event Type  malfunction  
Manufacturer Narrative
The device is expected to be returned for evaluation.It is yet to be received.
 
Event Description
The customer reported a microclave neutral connector that blood backed up our of the extended dwell through the clave and bled out onto the pillow.There is patient involvement and an unspecified patient injury.No additional information was provided.
 
Manufacturer Narrative
H10: no product samples, videos, or photographs were returned for investigation.A device history review could not be conducted because no lot number(s) was/were identified.A probable cause cannot be identified based on the information that has been provided.Additional information in d10.
 
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Brand Name
MICROCLAVE NEUTRAL CONNECTOR
Type of Device
SET, ADMINISTRATION, INTRAVASCULAR
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 Key10830142
MDR Text Key216164024
Report Number9617594-2020-00484
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
PMA/PMN Number
K100434
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,health profession
Type of Report Initial,Followup
Report Date 10/23/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/12/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberB3300
Device Catalogue NumberB3300
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Date Manufacturer Received11/30/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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