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 Known Impact Or Consequence To Patient (2692)

Event Date 07/25/2018

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 the bmt unit, a picc line was connected to a needless valve, which was connected to a bifuse, which was connected to tubing.There was difficulty disconnecting the bifuse from the needless valve, and the tip of the bifuse broke off into the needless valve.A cap change was performed.There was no patient harm.

Manufacturer Narrative

The customer's report that the tip of the bifuse set broke off was confirmed.Visual inspection showed that the tip of the set was broken off with the broken off piece lodged within the entrance end of the mating maxzero valve.A non-bd alcohol impregnated disinfecting cap was attached to one of the set's two maxzero valves.Further visual inspection of the broken luer tip showed whitish-colored stress markings on each side.The root cause of the customer's report could not be determined, however the breakage is likely due to excess force being applied; this may be related to insufficient drying time of the alcohol before the components are mated which can cause the items to be stuck together, making them difficult to detach.

Event Description

The customer reported that on the bmt unit, a picc line was connected to a needleless valve, which was connected to a bifuse, which was connected to tubing.There was difficulty disconnecting the bifuse from the needleless valve, and the tip of the bifuse broke off into the needleless valve.A cap change was performed.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: 7975824
• MDR Text Key: 124082383
• Report Number: 9616066-2018-01961
• 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: 10/29/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NON-BD DISINFECTING CAP; PRI TUBING,MZ1000-07, PICC LINE, TD (B)(6) 2018