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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 B1455
Device Problems Crack (1135); Fluid/Blood Leak (1250)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/13/2022
Event Type  malfunction  
Event Description
20 mins after line change, picc noted to be backing up with blood.Upon further inspection bed linen wet and tubing noted to be leaking fluid from area between trifuse and extension piece.2nd rn called to bedside to verify leaking and noted crack along hub extension piece.Piece replaced using sterile technique per protocol.Label placed that extension was no longer sterile and note placed in patient's sticky note/chart indicating that extension piece will need to be changed with tubing.Extension piece saved in bag and placed under educator¿s door.Manufacturer response for iv tubing, (brand not provided) (per site reporter) handled by site.Mail sent to rep requesting rma and mailer.Fedex label received sample shipped.Icu med reference #(b)(4).
 
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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 Key15137954
MDR Text Key296963299
Report Number15137954
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 07/22/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/01/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Model NumberB1455
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/22/2022
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA07/22/2022
Event Location Hospital
Date Report to Manufacturer08/01/2022
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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