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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ICU MEDICAL, INC. ICU MEDICAL; STOPCOCK, I.V. SET
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ICU MEDICAL, INC. ICU MEDICAL; STOPCOCK, I.V. SET Back to Search Results
Model Number B1115
Device Problem Material Separation (1562)
Patient Problem Insufficient Information (4580)
Event Date 11/14/2022
Event Type  malfunction  
Event Description
Tpn tubing filter sent from pharmacy came apart at filter section x2.Parts not supposed to come apart at this section.Lot number bag 5881552.Requested different lot number from pharmacy for 3rd change.
 
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Brand Name
ICU MEDICAL
Type of Device
STOPCOCK, I.V. SET
Manufacturer (Section D)
ICU MEDICAL, INC.
951 calle amanecer
san clemente CA 92673
MDR Report Key16013591
MDR Text Key305796270
Report Number16013591
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 Other Health Care Professional
Type of Report Initial
Report Date 12/13/2022,11/29/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/20/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Model NumberB1115
Device Catalogue NumberB1115
Device Lot Number5881552
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA12/13/2022
Date Report to Manufacturer12/20/2022
Type of Device Usage Unknown
Patient Sequence Number1
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