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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. TEGO CONNECTOR; SET, ADMINISTRATION, INTRAVASCULAR
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ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. TEGO CONNECTOR; SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Catalog Number D1000
Device Problems Crack (1135); Fluid/Blood Leak (1250)
Patient Problems No Consequences Or Impact To Patient (2199); Blood Loss (2597)
Event Date 10/15/2020
Event Type  malfunction  
Manufacturer Narrative
The device was discarded and is not available for evaluation.Without the returned device, a probable cause is unable to be determine.
 
Event Description
The events occurred involved the tego connector that the customer reported the product cracked, and leaked blood.The event happened on day two of their dialysis for the week.There was patient involvement, and no human harm.
 
Manufacturer Narrative
H11: subsequent to the submission of the initial medical device report, the customer provided additional information stating the event did not occur on the date of (b)(6) 2020, therefore, this medical device report was inadvertently submitted.
 
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Brand Name
TEGO 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 Key10983310
MDR Text Key220674140
Report Number9617594-2020-00533
Device Sequence Number1
Product Code FPA
UDI-Device Identifier00840619026059
UDI-Public(01)00840619026059(17)240901(10)4362825
Combination Product (y/n)N
PMA/PMN Number
K053106
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 11/17/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/10/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberD1000
Device Lot Number4362825
Was Device Available for Evaluation? No
Date Manufacturer Received12/14/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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