Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 28 CM (11") ADD-ON SET W/2 CHECK VALVES, VENTED CAP, NON-DEHP; STOPCOCK, I.V. SET
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 28 CM (11") ADD-ON SET W/2 CHECK VALVES, VENTED CAP, NON-DEHP; STOPCOCK, I.V. SET Back to Search Results
Catalog Number 011-H3393
Device Problem Material Separation (1562)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/18/2024
Event Type  malfunction  
Event Description
It was reported that a 28 cm (11") add-on set w/2 check valves, vented cap, non-dehp, separated after treatment was completed.¿at the end of the treatment, the pump rings an alarm: flow error.The nurse tightens the screw threads of the chemotherapy device tree (not connected to chemotherapy).The chemotherapy device tree has separated below the cap.¿ the patient is doing well before, during, and after the incident.No human harm, no need for medical intervention, no loss of blood, no delay in therapy.The medication was fully administered.No physical default on the device before use.There was an unscrewing of a branch of the chemotherapy tree.No need for medical intervention for the nurse and no exposure to cytotoxic medication.The product is not available for evaluation.There was no patient harm reported.
 
Manufacturer Narrative
Although the device was requested to be returned for evaluation, it has not been received.Without the returned device, a probable cause is unable to be determined.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
28 CM (11") ADD-ON SET W/2 CHECK VALVES, VENTED CAP, NON-DEHP
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 Key18728984
MDR Text Key335961775
Report Number9617594-2024-00165
Device Sequence Number1
Product Code FMG
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K964435
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Pharmacist
Type of Report Initial
Report Date 02/18/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/19/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number011-H3393
Device Lot Number13710170
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/19/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/01/2023
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
UNSPECIFIED FLUID, UNK MFR
-
-