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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ICU MEDICAL, INC. MICROCLAVE; STOPCOCK, I.V. SET
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ICU MEDICAL, INC. MICROCLAVE; STOPCOCK, I.V. SET Back to Search Results
Catalog Number A1135
Device Problem Break (1069)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/06/2019
Event Type  malfunction  
Event Description
During normal activity, the t connector extension set broke apart.This left the central line open to air and pain medication was delayed.Lines were clamped and tubing was immediately changed.This occurred on at least three different neonatal patients.The original packaging was not saved, however, the following two lot numbers were found on the remaining unused stock: 4070982, 4088593.Manufacturer response for 6"(15cm) appx 0.42ml, smallbore ext set w/check valve, nanoclave, nanoclave t connector, 2 clamps, rotating luer, (brand not provided) (per site reporter).Icumedical does not have a substitute today but expects it on monday and will ship overnight as soon as possible.
 
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Brand Name
MICROCLAVE
Type of Device
STOPCOCK, I.V. SET
Manufacturer (Section D)
ICU MEDICAL, INC.
951 calle amanecer
san clemente CA 92673
MDR Report Key9601437
MDR Text Key175413994
Report Number9601437
Device Sequence Number1
Product Code FMG
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 11/11/2019,11/08/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Catalogue NumberA1135
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/11/2019
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA11/11/2019
Event Location Hospital
Date Report to Manufacturer01/17/2020
Initial Date Manufacturer Received Not provided
Initial Date FDA Received01/17/2020
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Age16 DA
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