MAUDE Adverse Event Report: CAREFUSION MAXPLUS TRI-FUSE SET; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	MP9220-C
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/21/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: 3ml bd syringe of 0.9% sodium chloride injection, usp (bd 3ml, lot 804411c, ref 306508, exp: 2021-2-12); green curos swab cap.The customer¿s report that the tri-fuse leaked was confirmed.Visual inspection showed that one of its female luer components had multiple vertical hair line cracks that measured approximately 0.0390 to 0.1230 inches long.The cracks were observed to be running parallel to the direction of fluid flow.No stress/ tool marks were observed on the cracked luer.During functional and pressure testing a leak was observed as fluid flowed through one of the cracks.The root cause of the cracks was not definitively determined.
Event or Problem Description
The customer reported that the tri-connector used to connect the fluids to the picc appeared to have leaked which prevented the fluids from running through the tubing properly.The clinician changed the connector resulting in no further complications.A hct was performed and was within normal limits.There was no patient harm.

• Brand Name: MAXPLUS TRI-FUSE SET
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 7981132
• Report Number: 9616066-2018-01918
• Device Sequence Number: 1195265
• Product Code: FPA
• UDI-Device Identifier: 10885403237003
• UDI-Public: 10885403237003
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 09/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/19/2021
• Device Model Number: MP9220-C
• Device Catalogue Number: MP9220-C
• Device Lot Number: 18026168
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/11/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/18/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 2 MO