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

Model Number MBC6010

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

Unable to determine the cause of the customer's reported complaint 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 a generalized complaint regarding their blood collection devices that have occurred frequently over the past 2-3 months in the er.They state there is leaking from the 'gray stem' of the vacutainer onto both the patient and/or the clinician; there was no harm reported to either as a result of these events.

• Brand Name: BLOOD COLLECTION DEVICE W/MALE LUER
• Type of Device: SYSTEM, BLOOD COLLECTION,VACUUM-ASST
• 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: 5389225
• MDR Text Key: 36804874
• Report Number: 9616066-2016-00121
• Device Sequence Number: 1
• Product Code: KST
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/01/2017
• Device Model Number: MBC6010
• Device Catalogue Number: MBC6010
• Device Lot Number: 140420
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/07/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/03/2014
• 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