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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. APPX 1.0 ML, ADATTATORE PER POMPA CON SPIROS¿; STOPCOCK, I.V. SET
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ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. APPX 1.0 ML, ADATTATORE PER POMPA CON SPIROS¿; STOPCOCK, I.V. SET Back to Search Results
Catalog Number 011-H2629
Device Problem Fluid/Blood Leak (1250)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/09/2024
Event Type  malfunction  
Manufacturer Narrative
The device was received for evaluation.The investigation is pending.
 
Event Description
The event involved a appx 1.0 ml, adattatore per pompa con spiros¿ where the reporter stated that at the day oncology hospital, during the administration of a fluorouracil, therapy coming from the pharmacy, the nurses detected a leakage of medication between the connection from ch-14 (chemoclave® vented bag spike) and the h2629 device, which stopped when they switched to a new ch-14.The event occurred during patient use, there was delay in therapy, it is unknown if there was adverse event, and no one was harmed as a result of this event.
 
Manufacturer Narrative
A video was provided showing a 034-ch-14 connected to an h2629.Leakage was observed around the spiros.Received one opened/unused 011-h2629 transfer set w/spiros for inspection.Received one new 034-ch-14, one used 034-ch-14, and one used list #unknown chemolock port under (b)(4).The product from the video was not returned.No damages or anomalies noted.The 011-h2629 was leak tested individually and connected to the 034-ch-14.No leakage.The reported complaint of leakage can be confirmed from the video provided.The probable cause is unknown.Without the return of the used sample a comprehensive failure investigation cannot be performed and a cause cannot be determined.The lot history was reviewed and no nonconformities were identified that may have contributed to the reported complaint.
 
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Brand Name
APPX 1.0 ML, ADATTATORE PER POMPA CON SPIROS¿
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 Key18866600
MDR Text Key337227763
Report Number9617594-2024-00246
Device Sequence Number1
Product Code FMG
Combination Product (y/n)N
Reporter Country CodeSP
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 Administrator/Supervisor
Type of Report Initial,Followup
Report Date 04/09/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/08/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number011-H2629
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/26/2024
Date Manufacturer Received03/14/2024
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
CHEMOCLAVE® VENTED BAG SPIKE (LIST #CH-14), ICU ME.; FLUOROURACIL, MFR UNK.
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