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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. 14" (36 CM) APPX 3.6 ML, TRANSFER SET W/4 CLAVE¿, 2 TRI-CONNECTORS, BACK CHECK V; STOPCOCK, I.V. SET
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ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 14" (36 CM) APPX 3.6 ML, TRANSFER SET W/4 CLAVE¿, 2 TRI-CONNECTORS, BACK CHECK V; STOPCOCK, I.V. SET Back to Search Results
Catalog Number B33973
Device Problems Break (1069); Fluid/Blood Leak (1250)
Patient Problems Chemical Exposure (2570); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/05/2022
Event Type  malfunction  
Manufacturer Narrative
The device is not available for investigation.Without the return of the device a probable cause is unable to be determined.If additional information becomes available a supplemental report will be submitted.
 
Event Description
The event involved 14" (36 cm) appx 3.6 ml, transfer set w/4 clave¿, 2 tri-connectors, back check valve, clamp (blue), vented cap where the customer reported that the manifold tubing broke at the connection prior to adding blue chemo clip on when going to give a chemotherapy agent.The medication was clamped at the time and was able to be given.A dextrose 5% in water (d5w) plus residual cellcept® (mycophenolate mofetil) (approximately 20ml) fell and soaked into rn¿s shoes.The area was cleaned appropriately, and the tubing was changed.There was a patient involved and patient harm.No further information was provided about the patient¿s harm.The customer also added that she is not aware about the harm or medical intervention, but the hazardous medication was spilled on the nursing staff.
 
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Brand Name
14" (36 CM) APPX 3.6 ML, TRANSFER SET W/4 CLAVE¿, 2 TRI-CONNECTORS, BACK CHECK V
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
Manufacturer Contact
reed covert
600 n. field dr.
lake forest, IL 60045
2247062300
MDR Report Key19042413
MDR Text Key340109244
Report Number9617594-2024-00364
Device Sequence Number1
Product Code FMG
UDI-Device Identifier00(01)(17)(10)
UDI-Public(01)(17)(10)
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K964435
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Nurse
Type of Report Initial
Report Date 04/04/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/04/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberB33973
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/05/2024
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
Treatment
CELLCEPT® (MYCOPHENOLATE MOFETIL), MFR UNK; DEXTROSE 5% IN WATER (D5W), MFR UNK; UNSPECIFIED CHEMOTHERAPY AGENT, MFR UNK
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