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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. CHEMOCLAVE® VIAL SPIKE, 13MM; ADMINISTRATION SETS AND ACCESSORIES
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ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. CHEMOCLAVE® VIAL SPIKE, 13MM; ADMINISTRATION SETS AND ACCESSORIES Back to Search Results
Catalog Number SH-62
Device Problem Particulates (1451)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/01/2019
Event Type  malfunction  
Manufacturer Narrative
Device return has been requested, however, no device has been received for testing and investigation.
 
Event Description
The date of the event is unknown.The customer reported that they used an 18g needle to puncture the vial stopper and foreign substance appeared.The foreign substance was noticed after the needle was withdrawn.There was no reported harm associated with this event.
 
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Brand Name
CHEMOCLAVE® VIAL SPIKE, 13MM
Type of Device
ADMINISTRATION SETS AND ACCESSORIES
Manufacturer (Section D)
ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.
avenida cuarzo no. 250
ensenada, b.cfa. 22790
MX  22790
Manufacturer Contact
emily arnould, bsn, rn
600 n. field dr.
lake forest, IL 60045
2247062300
MDR Report Key8692728
MDR Text Key147778932
Report Number9617594-2019-00174
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K081361
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 05/28/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/12/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberSH-62
Device Lot NumberUNKNOWN
Is the Reporter a Health Professional? Yes
Date Manufacturer Received05/28/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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