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

Model Number MZ1000-07

Device Problems Occlusion Within Device (1423); Pressure Problem (3012)

Patient Problem Infiltration into Tissue (1931)

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: bd diffusics peripheral catheter, unknown gauge, model and lot number.Medrad power injector tubing, unknown model and lot number; medrad power injector device, unknown model and serial number.Therapy date unknown.No product will be returned per customer.The customer¿s complaint could not be confirmed because the product was not sequestered and will not be returned for failure investigation.The root cause of this failure was not identified.

Event Description

The customer reported that during an infusion for a ct procedure using a medrad power injector, the maxzero connector caused the infusion to not flow as expected from the medrad tubing to the patient¿s diffusics iv catheter, and the user stated that the line was ¿pressuring out on any injections requiring 4.0 ml/sec.¿ the patency of the iv catheter prior to the infusion and the gauge of the iv catheter were not provided.The ct tech theorized that the inhibition of flow caused an infiltration of the medication out of the patient¿s vein.The procedure was stopped and rescheduled after the event.No other effect to the patient was reported, and the products were not saved.

• Brand Name: MAXZERO NEEDLELESS CONNECTOR
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• Manufacturer (Section G): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• Manufacturer Contact: stephen bilello ; 10020 pacific mesa blvd; san diego, CA 92121-4386 ; 8586172000
• MDR Report Key: 6734029
• MDR Text Key: 80721378
• Report Number: 9616066-2017-01031
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K132413
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: MZ1000-07
• Device Catalogue Number: MZ1000-07
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/28/2017
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other