MAUDE Adverse Event Report: CAREFUSION NEEDLE-FREE VALVE; SET, ADMINISTRATION, INTRAVASCULAR

Model Number 2000E

Device Problem Break (1069)

Patient Problems Death (1802); No Known Impact Or Consequence To Patient (2692)

Event Date 06/21/2016

Event Type  Death  

Manufacturer Narrative

Although requested, the affected product has not been received.A follow up report will be submitted with investigation results should the devices be received for evaluation.

Event Description

Received a copy of the customer's medwatch report from the fda which states, "while changing the picc dressing and injection caps, the proximal white lumen was noted to have the center plastic piece of the chemo cap floating/lodged in lumen.Several attempts were made to remove the plastic part without success.Picc had to be removed and patient is scheduled to have another picc line done." there was no lasting harm.

Manufacturer Narrative

Additional information: no product will be returned per the customer.The customer complaint could not be confirmed because the product was discarded and not returned for failure investigation.The root cause of this failure was not identified.

Event Description

It was subsequently reported that the patient tolerated the new picc line placement, however, unrelated to this event, later passed away.

• Brand Name: NEEDLE-FREE VALVE
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• 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: 5811036
• MDR Text Key: 50058367
• Report Number: 9616066-2016-00926
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K061285
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date: 07/05/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/01/2019
• Device Model Number: 2000E
• Device Catalogue Number: 2000E
• Device Lot Number: 16027055
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/27/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/24/2016
• 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
• Patient Outcome(s): Death; Other
• Patient Age: 71 YR
• Patient Weight: 96