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

Model Number	MZ5307
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/26/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Although requested, product has not been received.A follow up report will be submitted with failure investigation results should the product be received for evaluation.
Event or Problem Description
It was reported that the bi-fuse connector cracked when the nurse went to cap the tubing with an alcohol impregnated cap on the general medicine transplant unit.The customer states that there was no patient injury.
Event or Problem Description
It was reported that when the iv fluids were discontinued, the nurse placed an alcohol impregnated cap on the bi-fuse connector and it cracked on the general medicine transplant unit.The customer states that there was no patient injury.
Additional Manufacturer Narrative
The customer¿s report that the bi-fuse connector cracked was confirmed to be a crack on the male luer collar.Received from the customer was one used extension set model mz5307 lot unknown.The set was received with blue disinfecting caps on the female luer ports and also the male luer end.Visual inspection observed that the male spin collar on the suspect extension set had one crack running parallel to the direction of the flow.Dimensional testing using the go/no go gauge showed the mail luer is within specification.Closer inspection under a lab microscope observed no tool marks and no stress marks.Dimensional testing using the go/no go gauge showed the mail luer to be within specification.The root cause could not be determined.

• Brand Name: MINIBORE BI-FUSE PRESSURE 2 IV CONNECTOR
• Common Device Name: SET, ADMINISTRATION, INFUSION
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 8609708
• Report Number: 9616066-2019-01293
• Device Sequence Number: 11347796
• Product Code: FPA
• UDI-Device Identifier: 10885403230615
• UDI-Public: 10885403230615
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K140831
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 04/22/2019

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
• Operator of Device: Health Professional
• Device Model Number: MZ5307
• Device Catalogue Number: MZ5307
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/15/2019
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/14/2019
• Supplement Report FDA Received Date: 06/28/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 2 FEMALE LUER DUALCAP,1 MALE LUER DUALCAP; ALCOHOL IMPREGNATED CAP, TD (B)(6)2019; ALCOHOL IMPREGNATED CAP, TD- (B)(6) 2019