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

Model Number MZ5307

Device Problem Fracture (1260)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/13/2018

Event Type  malfunction  

Manufacturer Narrative

Although requested, the affected product has not been received.A follow up report will be submitted with investigation results should the devices be received for evaluation.

Event Description

The customer reported that on 8wt bmt unit, a bifuse that was only 1 day old cracked during patient use.There was no patient harm.

Manufacturer Narrative

Additional information provided.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

The customer reported that on 8wt bmt unit, a bifuse that was only 1 day old cracked during patient use.There was no patient harm.

Event Description

The customer reported that on 8wt bmt unit, a bifuse that was only 1 day old cracked during patient use.There was no patient harm.

Manufacturer Narrative

The customer¿s report that the set cracked was confirmed.Visual inspection showed the set's exit luer component tip was broken off with the broken off piece lodged within the entrance end of a used maxzero valve.No other obvious damages or issues were observed.Functional testing was deemed unnecessary due to the breakage.The cause of the observed breakage was not determined but was likely related to excess force being applied.

• 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: 7969841
• MDR Text Key: 123847675
• Report Number: 9616066-2018-01936
• 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: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 09/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2018
• 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: 10/29/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: MZ1000-07, THERAPY DATE (B)(6) 2018; NON-BD DISINFECTING CAP