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 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.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 3ml 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 the connection to the bd 3ml syringe, during medication administration on a premature baby.Although specific patient impact for this event was requested, it was not provided.The customer further stated, that approximately 99% of the time, it was an antibiotic infusing when the leak was discovered.

Manufacturer Narrative

The customer¿s report of leaks occurring while using the bd 3ml syringes was confirmed.Visual inspection under magnification of the 3ml syringe observed a deformed area on the conical luer near the base of the luer tip.There were no other anomalies observed.Functional testing confirmed leaking at the engagement of the syringe and maxzero.The syringe was carefully detached.Inspection of the recently mated components observed no obvious damages or issues.Pressure testing resulted in no leaking.The root cause was identified as due to a damaged syringe luer tip.The cause of the damaged syringe luer tip was not determined.

• 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: 9532566
• MDR Text Key: 191262238
• Report Number: 9616066-2019-03767
• 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: 02/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 3ML BD SYRINGE, THERAPY DATE (B)(6) 2019