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

Model Number	MPX5302-C
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
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
The customer reported that they use the extension set on laboring patients who are receiving pitocin to strengthen labor contractions during childbirth.The extension tubing set has been found to be leaking iv fluids or blood from the nac-y needle-free valve that is located 4 inches from the spin male luer lock.There was no report of patient harm.
Additional Manufacturer Narrative
The customer¿s report of leaking extension sets was not confirmed.Visual inspection of the set noted no discernible signs of damage or abnormalities.Functional testing resulted in no leaking.The cause of the reported failure was not determined.
Event or Problem Description
The customer reported that they use the extension set on laboring patients who are receiving pitocin to strengthen labor contractions during childbirth.The extension tubing set has been found to be leaking iv fluids or blood from the nac-y needle-free valve that is located 4 inches from the spin male luer lock.There was no report of patient harm.

• Brand Name: 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: 7774271
• Report Number: 9616066-2018-01289
• Device Sequence Number: 16397096
• Product Code: FPA
• UDI-Device Identifier: 10885403237232
• UDI-Public: 10885403237232
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K083472
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/12/2018

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: 01/25/2023
• Device Model Number: MPX5302-C
• Device Catalogue Number: MPX5302-C
• Device Lot Number: 18016670
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/02/2018
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/10/2018
• Supplement Report FDA Received Date: 11/29/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1