MAUDE Adverse Event Report: CAREFUSION EXTENSION SET; SET,ADMINISTRATION,INTRAVASCULAR

Model Number	MP5310-C
Medical Device Problem Codes	Fluid/Blood Leak (1250); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/29/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No product will be returned per customer.The customer complaint could not be confirmed because the product was discarded and not returned for failure investigation.The root cause of this failure was not identified.
Event or Problem Description
It was reported that following a cardizem infusion through a peripheral iv, a nurse in the emergency room flushed the needleless valve with saline and experienced blood backing up into the extension tubing as the internal piston remained depressed when the syringe was disconnected.This product had been in use for twenty four hours.The customer states that there was no patient harm.

• Brand Name: EXTENSION SET
• Common Device Name: SET,ADMINISTRATION,INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 8656084
• Report Number: 9616066-2019-01463
• Device Sequence Number: 14014867
• 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: K051499
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/06/2019

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: 01/22/2022
• Device Model Number: MP5310-C
• Device Catalogue Number: MP5310-C
• Device Lot Number: 19016614
• 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: 05/30/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 78 YR