MAUDE Adverse Event Report: CAREFUSION MAXPLUS POSITIVE PRESSURE CONNECTOR; SET, EXTENSION, INTRAVASCULAR

Model Number MP1000-C

Device Problem Retraction Problem (1536)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/22/2019

Event Type  malfunction  

Manufacturer Narrative

Although requested, the affected product has not been received.A follow up report will be submitted with investigation results should the product be received for evaluation.Requested patient demographics however customer decline to provide.

Event Description

It was reported that maxplus connector experienced displacement issues.The event occurred on the cardiac telemetry unit.

Manufacturer Narrative

Date of event was reported as (b)(6) 2019.

Event Description

It was reported that maxplus connector experienced displacement issues.The event occurred on the cardiac telemetry unit.

• Brand Name: MAXPLUS POSITIVE PRESSURE CONNECTOR
• Type of Device: SET, EXTENSION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 8627470
• MDR Text Key: 145629744
• Report Number: 9616066-2019-01310
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10885403223228
• UDI-Public: 10885403223228
• Combination Product (y/n): N
• PMA/PMN Number: K072542
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Type of Report: Initial,Followup
• Report Date: 04/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/21/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MP1000-C
• Device Catalogue Number: MP1000-C
• Was Device Available for Evaluation?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1