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

Model Number MZ1000-07

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Information (3190)

Event Date 11/08/2019

Event Type  malfunction  

Manufacturer Narrative

Although requested, product has not been received.A follow up report will be submitted with failure investigation results should the device be received for evaluation.Patient's demographics requested, but was not provided.

Event Description

It was reported from the nicu that the maxzero leaked at connection to the bd 3 ml syringe during medication administration on a premature baby.Although specific patient impact for this event was requested, it was not provided.However; the customer stated that approximately 99% of the time, it was an antibiotic infusing when the leak occurred.

Event Description

It was reported from the nicu that the maxzero leaked at connection to the bd 3ml syringe during medication administration on a premature baby.However; the customer stated that approximately 99% of the time, it was an antibiotic infusing when the leak occurred.Although specifically requested, there has been no definitive impact to patient response or additional event information made available to date.

Manufacturer Narrative

Additional information provided: d.10.***************************************** the customer's report that the maxzero leaked at connection to the bd 3ml syringe was not confirmed.Visual inspection of the set noted no damage or any anomalies.No obvious damage or issue was observed with the received samples.Functional and pressure testing resulted in no leaking.The root cause was not identified.

• 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: 9532561
• MDR Text Key: 193982866
• Report Number: 9616066-2019-03766
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10885403230196
• UDI-Public: 10885403230196
• Combination Product (y/n): N
• PMA/PMN Number: K132413
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 12/09/2019

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: MZ1000-07
• Device Catalogue Number: MZ1000-07
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/30/2019
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 3 ML BD SYRINGE, THERAPY DATE (B)(6) 2019