MAUDE Adverse Event Report: CAREFUSION BLOOD COLLECTION DEVICE W/MALE LUER; SYSTEM, BLOOD COLLECTION, VACUUM-ASSISTED, MANUAL

Model Number MBC6010

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The customer's reported complaint could not be confirmed because the set has been discarded by the customer and will not be returned.The root cause of this failure could not be identified.

Event Description

Customer reported that the blood continued to flow out of the vacutainer while changing tubes.There was no harm to the clinician or patient as a result of the event, and no further information or details are available.

• Brand Name: BLOOD COLLECTION DEVICE W/MALE LUER
• Type of Device: SYSTEM, BLOOD COLLECTION, VACUUM-ASSISTED, MANUAL
• 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: 5402108
• MDR Text Key: 37240802
• Report Number: 9616066-2016-00185
• Device Sequence Number: 1
• Product Code: KST
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MBC6010
• Device Catalogue Number: MBC6010
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/22/2016
• Was Device Evaluated by Manufacturer?: No
• 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