MAUDE Adverse Event Report: CAREFUSION MINIBORE PRESSURE RATED EXTENSION; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	MP5313-C
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional 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.Patient age and dob was requested but not provided.
Event or Problem Description
The customer reported that the tubing set leaked in the women's & children's pediatric and nursery department during patient use which caused the patient to have the iv restarted.There was no report of patient harm.
Additional Manufacturer Narrative
The customer¿s report that the tubing leaked was confirmed to be torn and leaking tubing.Visual inspection of the set noted a tear in the tubing at the engagement to the female luer.Closer inspection under magnification observed the tear in the tubing to be jagged.No tool marks were observed.Closer inspection of the leak under a lab microscope observed a cut in the tubing.Functional testing confirmed leaking from the tear in the tubing at the engagement to the female luer.The root cause of the tubing leak is due to a small tear in the tubing.The root cause of the tear is unknown.
Event or Problem Description
The customer reported that the tubing set leaked in the women's & children's pediatric and nursery department during patient use which caused the patient to have the iv restarted.There was no patient harm.

• Brand Name: MINIBORE PRESSURE RATED EXTENSION
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 8429254
• Report Number: 9616066-2019-00716
• Device Sequence Number: 2989367
• Product Code: FPA
• UDI-Device Identifier: 10885403236716
• UDI-Public: 10885403236716
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K051499
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/04/2019

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: MP5313-C
• Device Catalogue Number: MP5313-C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/28/2019
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/18/2019
• Supplement Report FDA Received Date: 06/19/2019
• 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: HOSPIRA PLUM A DEVICE, THERAPY DATE UNK; HOSPIRA PLUM A DEVICE, THERAPY DATE UNK