MAUDE Adverse Event Report: CAREFUSION SMARTSITE® 3-WAY STOPCOCK; STOPCOCK, I.V. SET

Model Number 10011098

Device Problem Fluid/Blood Leak (1250)

Patient Problem High Blood Pressure/ Hypertension (1908)

Event Date 12/31/2015

Event Type  Injury  

Manufacturer Narrative

The affected product has been received and the investigation is pending.A follow up report will be submitted once the failure investigation has been completed.

Event Description

The customer reported that a patient receiving propofol and alfentanil infusions awoke and became hypertensive, and was "fighting the ventilator".Sedation was initially increased and a noradrenaline infusion was reduced.Upon inspection it was noticed that the set was leaking.The set was changed immediately, and no further intervention was reported.

Manufacturer Narrative

Conclusion code field left blank.No available code for undetermined or unknown cause.The customer¿s report of leaking was confirmed.Visual inspection observed hair line cracks on the female luer of the three-way stopcock; leakage was identified from the crack during pressure testing.The root cause was of the leaking was a crack in the female luer of the three-way stopcock.The cause of the crack is unknown.

• Brand Name: SMARTSITE® 3-WAY STOPCOCK
• Type of Device: STOPCOCK, I.V. SET
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• Manufacturer (Section G): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• Manufacturer Contact: stephen bilello ; 10020 pacific mesa blvd; san diego, CA 92121-4386 ; 8586172000
• MDR Report Key: 5383522
• MDR Text Key: 36539970
• Report Number: 9616066-2016-00079
• Device Sequence Number: 1
• Product Code: FMG
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K071400
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/04/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/21/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2018
• Device Model Number: 10011098
• Device Catalogue Number: 10011098
• Device Lot Number: 15046272
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/13/2017
• 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 Number: 1
• Treatment: MFX2265
• Patient Outcome(s): Required Intervention