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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. 13" SMALLBORE QUADFUSE EXT SET W/3 MICROCLAVE® (GLOW, 2 RED RINGS), 0.2 MICRON F; STOPCOCK, I.V. SET
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ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 13" SMALLBORE QUADFUSE EXT SET W/3 MICROCLAVE® (GLOW, 2 RED RINGS), 0.2 MICRON F; STOPCOCK, I.V. SET Back to Search Results
Catalog Number B33902
Device Problems Disconnection (1171); Fluid/Blood Leak (1250)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/30/2023
Event Type  malfunction  
Manufacturer Narrative
One (1) used sample list (b)(6) was returned for evaluation, as received it was confirmed that the tube came separated from filters.No additional damage or abnormally were observed.No mating device was returned.After visual inspection, there was no solvent presence in the tube, either in the filter.The complaint of disconnection / loose connection can be confirmed based in the physical sample evaluation.The probable cause was due to insufficient solvent applied during manual assembly process in ensenada.A device history review (dhr) lot review could not be conducted because no lot number(s) was/were identified.
 
Event Description
The incident involved a 13'' (33 cm) smallbore quadfuse ext set w/3 microclave® (glow, 2 red rings), 0.2 micron filter, 4 clamps, rotating luer.The customer reported that the filter was disconnectioning and leaking during infusion.He said that the disconnect was to the hard plastic of the filter like adhesive wasn¿t there.The medication involved were total parenteral nutrition (tpn) and lipids.There was no harm reported, but they drew complete blood count and monitored protein for the patient.This is the first of five reports.
 
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Brand Name
13" SMALLBORE QUADFUSE EXT SET W/3 MICROCLAVE® (GLOW, 2 RED RINGS), 0.2 MICRON F
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
michael visocnik
600 n. field dr.
lake forest, IL 60045
2247062300
MDR Report Key17435395
MDR Text Key320159031
Report Number9617594-2023-00475
Device Sequence Number1
Product Code FMG
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 Pharmacist
Type of Report Initial
Report Date 07/14/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/01/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberB33902
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/24/2023
Is the Reporter a Health Professional? Yes
Date Manufacturer Received07/14/2023
Was Device Evaluated by Manufacturer? Yes
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
LIPIDS, MFR UNK; TOTAL PARENTERAL NUTRITION (TPN), MFR UNK
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