MAUDE Adverse Event Report: CAREFUSION TEXIUM CLOSED MALE LUER; SET, ADMINISTRATION, INTRAVASCULAR

Model Number 10012241-0500

Device Problem Retraction Problem (1536)

Patient Problem No Information (3190)

Event Date 07/20/2019

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: flush syringe, port; cad nfv.Although requested, the affected product has not been received.A follow up report will be submitted with investigation results should the product be received for evaluation.

Event Description

It was reported that the user noticed on the texium closed male luer with female cap had a valve issue ( piston slanted) and made it difficult to remove.The rn had to cap the needle port line remove the needless connector and then add the flush syringe to provide a post therapy flush.

• Brand Name: TEXIUM CLOSED MALE LUER
• 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: sylvia ventura ; 10020 pacific mesa blvd; san diego, CA 92121-4386 ; 8586172000
• MDR Report Key: 8913247
• MDR Text Key: 155107046
• Report Number: 9616066-2019-02375
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10885403221705
• UDI-Public: 10885403221705
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K053049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 07/22/2019

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 Expiration Date: 02/22/2022
• Device Model Number: 10012241-0500
• Device Catalogue Number: 10012241-0500
• Device Lot Number: 19026458
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/20/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/22/2019
• 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