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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. 60" (152 CM) APPX 0.41 ML, SMALLBORE EXT SET W/CLAMP, ROTATING LUER; STOPCOCK, I.V. SET
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ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 60" (152 CM) APPX 0.41 ML, SMALLBORE EXT SET W/CLAMP, ROTATING LUER; STOPCOCK, I.V. SET Back to Search Results
Catalog Number 144020460
Device Problems Crack (1135); Fluid/Blood Leak (1250)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/13/2024
Event Type  malfunction  
Manufacturer Narrative
One used.List #144020460 was returned for evaluation.As received a crack was observed on the female luer and a papaverine with sodium acetate residuals was observed inside.No mating device was returned for evaluation.The set was tested as per procedure and leaks coming from crack on the female luer was confirmed.The complaint of leaks can be confirmed.The probable cause of the crack is due to environmental stress during use.The lot history was reviewed, no nonconformities were identified that may have contributed to the reported complaint.
 
Event Description
The event involved a 60" (152 cm) appx 0.41 ml smallbore ext set w/clamp rotating luer where it was reported that the tubing was leaking at the connection site to the medication syringe.The event occurred during infusion of papaverine which was infusing with sodium acetate, on a peripheral arterial line.There were no holes, cuts, tears, or any defect that was visible noted.There was bleed back, however, no blood loss due to it being corrected before any blood loss occurred.There was patient involvement, but no patient harm reported.
 
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Brand Name
60" (152 CM) APPX 0.41 ML, SMALLBORE EXT SET W/CLAMP, ROTATING LUER
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 Key19086861
MDR Text Key340600532
Report Number9617594-2024-00401
Device Sequence Number1
Product Code FMG
UDI-Device Identifier00887709094154
UDI-Public(01)00887709094154(17)281101(10)13833041
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 04/11/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/11/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number144020460
Device Lot Number13833041
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/27/2024
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/14/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/01/2023
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
PAPAVERINE, UNK MFR.; PERIPHERAL ARTERIAL LINE, UNK MFR.; SODIUM ACETATE, UNK MFR.; SYRINGE, UNK MFR.
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