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

Model Number	42405E-07
Medical Device Problem Codes	Fluid/Blood Leak (1250); Material Separation (1562)
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 evaluation is pending.A follow up report will be submitted once the evaluation is completed.
Event or Problem Description
The customer reported separation and leaking at both connection points attaching to the stop-cock during patient use.There was no patient harm.
Additional Manufacturer Narrative
The customer¿s report of separation of the stopcock was confirmed visually upon receipt but was not replicated.The customer¿s report of a leak was not confirmed.During inspection the 4-way stopcock was observed to be completely separated from the upper and lower portions of tubing to which it had been connected during product assembly.After reconnecting the stopcock to both pieces of the separated tubing and securely tightening both luer connections, the customer-provided set was functioning effectively throughout testing, and no disconnections, loosening, or leaking occurred at any time.The root cause of the customer¿s experience was failure to tighten the stopcock connections prior to use as instructed in the directions for use.
Event or Problem Description
The customer reported separation and leaking at both connection points attaching to the stop-cock during patient use.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: 7856019
• Report Number: 9616066-2018-01552
• Device Sequence Number: 13944753
• 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: company representative,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/13/2018

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: 12/20/2020
• Device Model Number: 42405E-07
• Device Catalogue Number: 42405E-07
• Device Lot Number: 17126592
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/16/2018
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/07/2018
• Supplement Report FDA Received Date: 12/03/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1