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

Model Number	MP5310-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
Report source: project coordinator.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
Customer advocacy received a copy of the customer's medwatch report from the fda which states, "the iv loop "maxplus pressure rated extension set with clear needleless connector" has a small blue piece that recoils to close the iv connection and keep pressure in the tubing.When disconnecting lure lock syringes of any kind the blue piece will inconsistently stay depressed, allowing for fluids/blood to leak back out of the tube.A patient could lose a significant amount of blood if this were to go unnoticed." an incomplete date of event of (b)(6) 2019 was provided.This occurred in the emergency department and there was no harm.

• 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: 8412071
• Report Number: 9616066-2019-00726
• Device Sequence Number: 1785426
• Product Code: FPA
• UDI-Device Identifier: 10885403236686
• UDI-Public: 10885403236686
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K083472
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other,use
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/28/2019

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 Expiration Date: 10/20/2021
• Device Model Number: MP5310-C
• Device Catalogue Number: MP5310-C
• Device Lot Number: 18106550
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/12/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 42 YR