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

Model Number	42405E-07
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/14/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The affected product has been received and the evaluation is pending.A follow up report will be submitted once the evaluation is completed.
Event or Problem Description
The customer reported the set separated at a location other than next to the stock-cock.There was no patient harm.
Additional Manufacturer Narrative
The customer¿s report that the tubing separated was confirmed.Visual inspection of the set showed that there was a separation between the tubing and the male luer located near the stopcock.Insufficient solvent was observed around the end of the tubing where the separation occurred.The separated tubing was measured and the outer diameter was found to be within specification.The root cause of the separation is insufficient solvent during the manufacturing process.
Event or Problem Description
The customer reported the set separated at a location other than next to the stopcock.There was no patient harm.
Event or Problem Description
The customer reported the set separated at a location other than next to the stopcock.There was no patient harm.

• Brand Name: ALARIS® GRAVITY ADMINISTRATION SET
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 7860603
• Report Number: 9616066-2018-01570
• Device Sequence Number: 19469762
• Product Code: FPA
• UDI-Device Identifier: 10885403238611
• UDI-Public: 10885403238611
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K931173
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/14/2018

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 Expiration Date: 11/22/2020
• Device Model Number: 42405E-07
• Device Catalogue Number: 42405E-07
• Device Lot Number: 17118260
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/29/2018
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 09/10/2018
• Supplement Report FDA Received Date: 12/03/2018; 02/01/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1