MAUDE Adverse Event Report: CAREFUSION MINIBORE BI-FUSE PRESSURE 2 IV CONNECTOR; SET, ADMINISTRATION, INTRAVASCULAR

Model Number MZ5307

Device Problems Fracture (1260); Failure to Disconnect (2541)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/07/2018

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.

Event Description

An unexpected return was received for an unspecified reason.The customer later reported that on 9wt hematology/oncology, they were unable to remove the bifuse from the needless connector, as after being cracked, the collar of the bifuse wouldn't line up with the thread of the needlefree valve.A cap change was performed.There was no report of patient harm.

Manufacturer Narrative

The customer¿s report that the spin collar broke and could not disconnect the needleless valve was confirmed.Visual inspection showed that the male spin collar had a crack running parallel to the direction of the fluid flow.Further inspection under magnification showed that the ridges on the male luer, which are used for leverage for disconnecting, were stripped.Dimensional testing showed that the male luer tip was within specification.The root cause of the product breakage is excessive force being applied to the product when attempting to disconnect.

Event Description

An unexpected return was received for an unspecified reason.The customer later reported that on 9wt hematology/oncology, they were unable to remove the bifuse from the needleless connector, as after being cracked, the collar of the bifuse wouldn't line up with the thread of the needlefree valve.A cap change was performed.There was no report of patient harm.

• Brand Name: MINIBORE BI-FUSE PRESSURE 2 IV CONNECTOR
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 8017107
• MDR Text Key: 125430938
• Report Number: 9616066-2018-02028
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10885403230608
• UDI-Public: 10885403230608
• Combination Product (y/n): N
• PMA/PMN Number: K140831
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 09/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/29/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MZ5307
• Device Catalogue Number: MZ5307
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/26/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: MZ1000-07, THERAPY DATE (B)(6) 2018
• Patient Age: 15 YR