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. 112" 15 DROP PRIMARY SET W/3 MICROCLAVE®, 3-PORT NANOCLAVE® MANIFOLD, CHECK VALV; 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. 112" 15 DROP PRIMARY SET W/3 MICROCLAVE®, 3-PORT NANOCLAVE® MANIFOLD, CHECK VALV; STOPCOCK, I.V. SET Back to Search Results
Catalog Number AM3020
Device Problem Premature Activation (1484)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/22/2024
Event Type  malfunction  
Event Description
The event involved a 112" 15 drop primary set w/3 microclave¿, 3-port nanoclave¿ manifold, check valve, rotating luer where it was reported the valves in the manifold seem to malfunction (specifically the port proximal to the patient).It was stated that the part that is having an issue is the third port on the manifold, closest to the patient/end of the set.The clinicians prime the set, close the roller clamp at the top, and then attach the syringes to the manifold for when they are ready to administer the medication.The port on the manifold closest to the patient is pulling the medication from the attached syringe on its own and into the patient.This occurred after the lines were primed and hooked up to the patient but prior to the start of infusion causing the medication to be delivered prematurely to the patient without a clinician administering it.There was patient involved, however, no patient harm and no delay in therapy.
 
Manufacturer Narrative
The device is available to be returned for evaluation; however, it has not yet been received.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
112" 15 DROP PRIMARY SET W/3 MICROCLAVE®, 3-PORT NANOCLAVE® MANIFOLD, CHECK VALV
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 Key19143167
MDR Text Key341244101
Report Number9617594-2024-00464
Device Sequence Number1
Product Code FMG
UDI-Device Identifier00887709088511
UDI-Public(01)00887709088511(17)270101(10)5759588
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 Other Health Care Professional
Type of Report Initial
Report Date 04/19/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/19/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberAM3020
Device Lot Number5759588
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/22/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/01/2022
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 SYRINGE, UNK MFR.
-
-