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

Model Number MZ1000

Device Problems Backflow (1064); Obstruction of Flow (2423)

Patient Problem Extravasation (1842)

Event Date 04/20/2019

Event Type  malfunction  

Manufacturer Narrative

The model#/catalog# identified is a carefusion product which is same or similar to a device that is approved for sale domestically.The domestic similar list number is mz1000-07.The 510k number provided in section g5 is for the domestic similar product.Although requested, device has not been received.A follow up report will be submitted with failure investigation results should the logs/device be received for evaluation.

Event Description

The reported feedback suggests that the device with extravasation of medication, serum at the insertion.From the reported information, the extent of patient injury as result of the extravasation has not been clarified.

• 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: 8608683
• MDR Text Key: 145002755
• Report Number: 9616066-2019-01324
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K132413
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 04/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/14/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/25/2020
• Device Model Number: MZ1000
• Device Catalogue Number: MZ1000
• Device Lot Number: 17097339
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/25/2017
• 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