MAUDE Adverse Event Report: CAREFUSION MAXPLUS® CLEAR NEEDLELESS CONNECTOR; SET, ADMINISTRATION, INTRAVASCULAR

Model Number MP1000C-0006

Device Problems Fluid/Blood Leak (1250); Fracture (1260)

Patient Problem Palpitations (2467)

Event Date 06/11/2018

Event Type  Injury  

Manufacturer Narrative

The model#/catalog# is a carefusion product which is same or similar to a device that is approved for sale domestically.The domestic similar list number is mp1000-c.The 510k number provided in section g5 is for the domestic similar product.The affected product has been received and the evaluation is pending.A follow up report will be submitted once the evaluation is completed.

Event Description

The report suggests that a patient began to experience palpitations and when the clinician checked the line they noticed a leak from a crack in the maxplus connector.

Manufacturer Narrative

The customer¿s report of a crack and leak was confirmed.Visual inspection observed a vertical hairline crack on the female luer component.Functional testing was performed; a leak was observed from the crack.The root cause of the customer¿s experience was not identified.

Event Description

The report suggests that a patient began to experience palpitations and when the clinician checked the line they noticed a leak from a crack in the maxplus connector.

• Brand Name: MAXPLUS® CLEAR NEEDLELESS CONNECTOR
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 7720006
• MDR Text Key: 115058637
• Report Number: 9616066-2018-01089
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• PMA/PMN Number: K072542
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 06/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/25/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/04/2022
• Device Model Number: MP1000C-0006
• Device Catalogue Number: MP1000C-0006
• Device Lot Number: 17075499
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/12/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: PICC AND EXTENSION SET VELTRI, TD (B)(6) 2018
• Patient Outcome(s): Other