MAUDE Adverse Event Report: CAREFUSION MAXPLUS CLEAR NEEDLE-FREE CONNECTOR; SET, EXTENSION, INTRAVASCULAR

Model Number MP1000

Device Problem Fluid/Blood Leak (1250)

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

Event Date 12/03/2019

Event Type  malfunction  

Manufacturer Narrative

The affected product has been received and the investigation is pending.A follow up report will be submitted once the failure investigation has been completed.

Event Description

The reported feedback suggests that there is a leakage.Customer that ¿bleeding¿ was noticed at the joint between the connector and the catheter.The nurse checked and found that the joint was loose and replaced with new connector.Subsequently, a day after the replacement of the new connector, it was noticed that while the connector was used for blood transfusion treatment ,leakage happened at the connector with tube joint.

Event Description

The reported feedback suggests that there is a leakage.Customer that ¿bleeding¿ was noticed at the joint between the connector and the catheter.The nurse checked and found that the joint was loose and replaced with new connector.Subsequently, a day after the replacement of the new connector, it was noticed that while the connector was used for blood transfusion treatment ,leakage happened at the connector with tube joint.

Manufacturer Narrative

Two mp1000 china samples from lot 16018065 were received for investigation.One in sealed packaging and one without packaging with residual blood present on the casing.Further information provided by the customer indicates that the leakage was observed due to a loose connection with the connecting product.The connecting product was not returned to assist the investigation.A visual inspection did not identify any product defects or manufacturing issues which could have caused or contributed to the customer's experience.Pressure testing of the sample received without packaging did not identify any leakage from the connection of the maxplus and a definitive root cause could not be determined.Furthermore pressure testing of the sample received in sealed packaging did not identify any leakage throughout testing.The details of this feedback were forwarded to the manufacturing site for investigation.A review of the production records for lot 16018065 did not identify any in-process testing failures or quality deviations which may have resulted in a report of this nature.It was not possible to confirm the root cause of the customer¿s experience in this instance.Testing of the returned sample did not identify any product defects or quality deviations that could have contributed to the customer¿s experience.A review of the customer feedback database indicates that this is an isolated occurrence with no further reports of this nature against the maxplus device over the past 12 months.

• Brand Name: MAXPLUS CLEAR NEEDLE-FREE CONNECTOR
• Type of Device: SET, EXTENSION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 9519990
• MDR Text Key: 190801509
• Report Number: 9616066-2019-03732
• 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
• Type of Report: Initial,Followup
• Report Date: 12/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MP1000
• Device Catalogue Number: MP1000
• Device Lot Number: 16018065
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/17/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/26/2019
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1