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

Model Number	10011253
Medical Device Problem Codes	Crack (1135); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Information (3190)
Date of Event	05/03/2019
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 "t piece extension" that was used on the patients art line was leaking.T piece was replaced with a new one and inspected.There was a crack noted along the plastic where the extension piece would connect to the pressure monitoring tubing.
Additional Manufacturer Narrative
The customer¿s report of a leak was confirmed to be a female luer crack.Visual inspection confirmed that the female luer had a lateral crack.Closer inspection under a lab microscope observed no tool marks or signs of over torque.The set was visually inspected for kinks, incomplete bonding engagements, holes/tears in the tubing or damages to the components.Visual inspection found a crack in the female luer wall on the opposite end of the injection gate of the suspect filter extension set.A priming test noted the set leaked from the cracked female luer.No other leaks were observed throughout the set.The source of the leak is due to a crack in the female luer component.The root cause of the crack is a result of internal stresses created in the luer during the manufacturing process.
Event or Problem Description
It was reported that the "t piece extension" that was used on the patients arterial line was leaking.T piece was replaced with a new one and inspected.There was a crack noted along the plastic where the extension piece would connect to the pressure monitoring tubing.

• Brand Name: ALARIS PRESSURE RATED EXTENSION SET
• Common Device Name: SET, EXTENSION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 8846572
• Report Number: 9616066-2019-02079
• Device Sequence Number: 2499127
• Product Code: FPA
• UDI-Device Identifier: 10885403233609
• UDI-Public: 10885403233609
• Combination Product (Y/N): N
• Initial Reporter State: AK
• Initial Reporter Country: US
• PMA/510(K) Number: K960280
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/03/2019

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: 10011253
• Device Catalogue Number: 10011253
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/30/2019
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/31/2019
• Supplement Report FDA Received Date: 10/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1