MAUDE Adverse Event Report: ICU MEDICAL, INC. INTRALOCK LIPID COMPATIBLE 3-WAY STOPCOCK

Model Number 42383-01

Device Problems Crack (1135); Fluid/Blood Leak (1250)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/16/2016

Event Type  malfunction  

Manufacturer Narrative

Lot# review: a review of lot# 3195717 showed that (b)(4).Not returned (discarded).

Event Description

Med sun mw5064071, complaint received regarding one 42383-01, intralock lipid compatible 3-way stopcock, lot# 3195717 (mfd.02/2016).Patient leaking blood out of his umbilical arterial catheter between the first and second stopcock on the transducer.Estimated blood loss of 5ml.Catheter was clamped with fingers between the insertion site and the introducer to prevent any more blood loss.The first two stopcocks on the transducer were replaced once disconnected with the patient.There was a crack noticed between the first and second stopcock on the transducer, where blood was leaking out.Patient was stable throughout event and monitored closely afterwards.Nnp and dr.Were notified and assessed patient.Orders were put in for one dose of vancomycin and to discontinue the umbilical arterial catheter.No adverse patient consequences reported.

• Brand Name: INTRALOCK LIPID COMPATIBLE 3-WAY STOPCOCK
• Type of Device: INTRALOCK LIPID COMPATIBLE 3-WAY STOPCOCK
• Manufacturer (Section D): ICU MEDICAL, INC.; 4455 atherton dr.; salt lake city UT 84123
• Manufacturer (Section G): ICU MEDICAL, INC.; 4455 atherton dr.; salt lake city UT 84123
• Manufacturer Contact: bob gillispie ; 4455 atherton dr.; salt lake city, UT 84123 ; 8012641702
• MDR Report Key: 5986734
• MDR Text Key: 56543125
• Report Number: 2025816-2016-00158
• Device Sequence Number: 1
• Product Code: FMG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K080077
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,use
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 09/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Expiration Date: 02/01/2019
• Device Model Number: 42383-01
• Device Catalogue Number: 42383-01
• Device Lot Number: 3195717
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/02/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/25/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1