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

Model Number MZ1000

Device Problem Fluid/Blood Leak (1250)

Patient Problem Hypoglycemia (1912)

Event Date 02/17/2020

Event Type  Injury  

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 was a leakage of drug through the device.From the reported information, the patient suffered hypoglycemia as a result of this incident.

Event Description

The reported feedback suggests that there was a leakage of drug through the device.From the reported information, the patient suffered hypoglycemia as a result of this incident.

Manufacturer Narrative

One mz1000 sample from lot 19115073 was received in sealed packaging for investigation of complaint reference inf-int-2020-000473 and inf-int-2020-000479.In addition, one alargador extension set and one heuer three-way tap were also returned in sealed packaging to assist the investigation.As part of the investigation, an empty mz1000 packaging from lot 19106164 was also received.A visual inspection of the returned mz1000 sample did not identify any product defects or manufacturing issues which could have caused or contributed to the customer¿s experience.In an attempt to replicate the customer's experience, the returned extension set and three-way tap were connected to the maxzero component; in each instance no leakage was identified throughout testing.The details of this feedback were forwarded to the manufacturing site for investigation.In this instance, a definitive root cause could not be identified as testing of the returned samples did not identify any product defects that could have contributed to the customer¿s experience.A review of the production records for lot 19115073 and 19106164 did not identify any in-process testing failures or quality deviations which may have resulted in a report of this nature.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 maxzero product.

• Brand Name: MAXZERO NEEDLELESS CONNECTOR
• Type of Device: SET,ADMINISRATION,INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 9861786
• MDR Text Key: 184422319
• Report Number: 9616066-2020-00830
• 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
• Type of Report: Initial,Followup
• Report Date: 02/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MZ1000
• Device Catalogue Number: MZ1000
• Device Lot Number: 19106164
• Was Device Available for Evaluation?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other