MAUDE Adverse Event Report: CAREFUSION MAXZERO NEEDLELESS CONNECTOR; SET,ADMINISTRATION,INTRAVASCULAR

Model Number MZ1000

Device Problem Reflux within Device (1522)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/17/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The reported feedback suggests that there is continuous blood return in the needless catheters when connected to short peripheral iv catheters.There was no leakage, however the catheter remained bloody inside despite constant flushing with a pre-filled syringe of saline.The customer stated that they only use the catheters of high clinical value, such as piccs, ccic and arterial lines where there is no return of blood.They changed to a different connector for use with the short peripheral catheters.

Manufacturer Narrative

A mz1000 sample was not available for investigation of this feedback; however the customer indicates that blood back flow was experienced during infusion.No further information was available to assist the investigation in this instance.The details of this feedback were forwarded to the manufacturing site for investigation.In this instance a lot number was not available and therefore it is not possible to perform a review of the production documentation for this particular product.The root cause of the customer¿s experience could not be determined in this instance.Without a sample it is not possible to determine whether a manufacturing defect could have caused or contributed to the reported issue.Please note as stated in the directions for use of the maxzero valve "flush the maxzero after each use with normal saline or in accordance with facility protocol." "failure to properly prime the device can result in reflux." a review of the customer feedback database indicates that complaints of this nature are rare and there is currently no trend for issues of this nature against the mz1000 product.H3 other text : see section h.10.

Event Description

The reported feedback suggests that there is continuous blood return in the needless catheters when connected to short peripheral iv catheters.There was no leakage, however the catheter remained bloody inside despite constant flushing with a pre-filled syringe of saline.The customer stated that they only use the catheters of high clinical value, such as piccs, ccic and arterial lines where there is no return of blood.They changed to a different connector for use with the short peripheral catheters.

• Brand Name: MAXZERO NEEDLELESS CONNECTOR
• Type of Device: SET,ADMINISTRATION,INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 9968400
• MDR Text Key: 196601966
• Report Number: 9616066-2020-01284
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• PMA/PMN Number: K132413
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other
• Type of Report: Initial,Followup
• Report Date: 03/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/16/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MZ1000
• Device Catalogue Number: MZ1000
• Was Device Available for Evaluation?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1