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

Model Number MZ1000-07

Device Problem Compatibility Problem (2960)

Patient Problem No Code Available (3191)

Event Date 09/04/2019

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: non-bd uvc catheter; 10ml bd syringe, lot #: 9150577, exp 2022-05-31, 0.9% sodium chloride injection; alcohol cap.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.Race: white; weight: not available; admitting diagnosis: extremely premature, respiratory distress.

Event Description

It was reported that after a patient had received blood transfusion though a umbilical vein catheter (uvc), the nurse was unable to clear the residual blood from the needle-free connector.The needle-free connector was replaced with a new one.While the rn was trying to complete flushing the line, the distal end of the uvc broke off with the needle-free connector and the rn was unable to clamp the line.The needle-free connector did not break, as the break occurred n the hub of the uvc line.The neonatal nurse practitioner was unable to insert another uvc despite a long attempt.The patient then had to have a percutaneous central venous catheter (pcvc) insertion and the fluids needed to be stopped for medication and blood products.It was noted by the user that the needle-free connector contributed to the break in the uvc line.The needle-free connectors were being changed out frequently because they were not clearing after blood draws despite correct line flushing procedures.

Event Description

It was reported that after a patient had received blood transfusion though a umbilical vein catheter (uvc), the nurse was unable to clear the residual blood from the needle-free connector.The needle-free connector was replaced with a new one.While the rn was trying to complete flushing the line, the distal end of the uvc broke off with the needle-free connector and the rn was unable to clamp the line.The needle-free connector did not break, as the break occurred in the hub of the uvc line.The neonatal nurse practitioner was unable to insert another uvc despite a long attempt.The patient then had to have a percutaneous central venous catheter (pcvc) insertion and the fluids needed to be stopped for medication and blood products.It was noted by the user that the needle-free connector contributed to the break in the uvc line.The needle-free connectors were being changed out frequently because they were not clearing after blood draws despite correct line flushing procedures.

Manufacturer Narrative

The customer¿s report of the distal end (hub) of the uvc broke off with the needle-free connector (maxzero) was confirmed.Visual inspection noted that one of the female luer hubs on the uvc was broken off.The broken section of the hub was not returned.No damage was observed on the other hub of the uvc.No damage was observed on the maxzero connecters or on the plus1 connectors.Functional testing performed using the second intact uvc hub to try to reproduce the break to the uvc line found no difficulty disconnecting and connecting the two components.External later force was also applied to the uvc hub with no breakage observed.Dimensional analysis was performed on the male luer side of the maxzero and was within iso specifications.The connecter was found to be within the required specifications.The root cause of the broken off hub 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: 9148230
• MDR Text Key: 161381538
• Report Number: 9616066-2019-02727
• 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: 09/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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: 09/17/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/02/2019
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: (2 )394910, (5) MZ1000-07, SYRINGE, TD (B)(6) 2019
• Patient Outcome(s): Required Intervention
• Patient Age: 2 DA