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, device has not been received.A follow up report will be submitted with failure investigation results should the device be received for evaluation.

Event Description

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

Manufacturer Narrative

The customer's report that the set cracked was confirmed.During visual inspection it was observed that the set's exit luer component was cracked where a non-bd alcohol impregnated disinfecting cap was attached.No obvious tool markings were observed around the damaged area or the rest of the set's components.The root cause was prolonged exposure of isopropyl alcohol to the luer component in combination with other possible contributing factors such as high hoop stress, over-tightening, extended use, and repeated connections/disconnections.

Event Description

The customer reported that on 8wt bmt unit, the bifuse cracked during patient use.The bifuse was only 1 day old.There was no 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: 7975826
• MDR Text Key: 125105760
• Report Number: 9616066-2018-01960
• 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
• Report Date: 09/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2018
• 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: 10/26/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NON-BD ALCOHOL IMPREGNATED DISINFECTING CAPS