MAUDE Adverse Event Report: CAREFUSION BLOOD COLLECTION DEVICE W/MALE LUER; BLOOD SET

Model Number MBC6000

Device Problem Material Separation (1562)

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

Event Date 03/22/2016

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer states that the blood collection assembly tip covering the transfer needle was dislodged during the transfer process, not allowing blood culture specimen to be used.

Manufacturer Narrative

The customer¿s report of the rubber sheath separating was confirmed.Visual inspection of the device revealed that the synthetic rubber sheath was missing.No other damages were found on the blood collection device.Functional testing was not performed due to the obvious damage.The root cause of the synthetic rubber sheath dislodging from the needle was not identified.

• Brand Name: BLOOD COLLECTION DEVICE W/MALE LUER
• Type of Device: BLOOD 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: ade ajibade ; 10020 pacific mesa blvd; san diego, CA 92121-4386 ; 8586172000
• MDR Report Key: 5533492
• MDR Text Key: 41416939
• Report Number: 9616066-2016-00499
• 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: company representative,distri
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 03/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: MBC6000
• Device Catalogue Number: MBC6000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/18/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/21/2016
• 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