MAUDE Adverse Event Report: CAREFUSION MAXGUARD® BLOOD COLLECTION TUBE HOLDER; SYSTEM, BLOOD COLLECTION,VACUUM-ASST

Model Number MBC6000

Device Problems Leak/Splash (1354); Mechanical Problem (1384)

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

Event Date 02/17/2016

Event Type  malfunction  

Manufacturer Narrative

No product will be returned per customer.The customer¿s complaint could not be confirmed because the product was not sequestered and will not be returned for failure investigation.The root cause of this failure was not identified.

Event Description

The customer reported that the rubber got stuck in the blood collection device and leaked.There is no report of any patient harm.

• Brand Name: MAXGUARD® BLOOD COLLECTION TUBE HOLDER
• 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: 5498277
• MDR Text Key: 40245594
• Report Number: 9616066-2016-00381
• Device Sequence Number: 1
• Product Code: KST
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/23/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/01/2017
• Device Model Number: MBC6000
• Device Catalogue Number: MBC6000
• Device Lot Number: 301141219
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/23/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/19/2014
• 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