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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. KOMPLETT-SET 8S PULT LANG; STOPCOCK, I.V. SET
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ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. KOMPLETT-SET 8S PULT LANG; STOPCOCK, I.V. SET Back to Search Results
Catalog Number S80800PL
Device Problem Particulates (1451)
Patient Problem No Patient Involvement (2645)
Event Date 05/27/2019
Event Type  malfunction  
Manufacturer Narrative
The device is available for testing.It is yet to be received.
 
Event Description
The customer reported a brown particle inside the front of the plunger of a komplett-set 8s pult lang device.The device was changed out with no further problems encountered.There was no patient involvement and no adverse event.
 
Manufacturer Narrative
H11: the manufacturer report number 9617594-2019-00193-00 is a duplicate of manufacturer report number 9617594-2019-00194-00 and was inadvertently submitted in error.The investigation results were reported under manufacturer report number.
 
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Brand Name
KOMPLETT-SET 8S PULT LANG
Type of Device
STOPCOCK, I.V. SET
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 Key8910710
MDR Text Key204588210
Report Number9617594-2019-00193
Device Sequence Number1
Product Code FMG
UDI-Device Identifier00840619065423
UDI-Public(01)00840619065423(17)210701(10)3731054
Combination Product (y/n)N
PMA/PMN Number
K964435
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 05/27/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/20/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date07/01/2021
Device Catalogue NumberS80800PL
Device Lot Number3731054
Was Device Available for Evaluation? Yes
Date Manufacturer Received08/06/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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