MAUDE Adverse Event Report: CAREFUSION ALARIS GRAVITY SET; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	10425228
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/05/2019
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.
Event or Problem Description
It was reported the tubing had a hole.There was no patient harm.
Additional Manufacturer Narrative
The customer¿s report of a damaged set tubing was confirmed.Visual inspection of the set was done for obvious issues/damage such as kinked tubing, pin holes, tears, disengagements, cracks, fractures, contaminants, incorrect orientation, and component misassembly further visual inspection of the set noted the distal extension portion of the set was not connected to the rest of the set.A slice cut was observed on the tubing between the female luer and smartsite component of the distal extension.Further examination under magnification measured the cut to be 0.11 inches in length.Also observed around the tubing area of the cut were indentations likely due to the engagement of the slide clamp.No other obvious damages were observed around the cut tubing area.Functional testing confirmed leaking at the cut area.Further inspection under magnification of the slide clamp observed no obvious flash or sharp edges.Pressure testing resulted in no leaking.The root cause of the damage was not identified.
Event or Problem Description
It was reported that the tubing has a hole in it midline.It was confirmed that there was no patient harm associated with this event.

• Brand Name: ALARIS GRAVITY SET
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 8967408
• Report Number: 9616066-2019-02447
• Device Sequence Number: 16682140
• Product Code: FPA
• UDI-Device Identifier: 10885403234248
• UDI-Public: 10885403234248
• Combination Product (Y/N): N
• Initial Reporter State: AK
• Initial Reporter Country: US
• PMA/510(K) Number: K820278
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 08/08/2019

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: 10425228
• Device Catalogue Number: 10425228
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/03/2019
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/05/2019
• Supplement Report FDA Received Date: 11/13/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1