MAUDE Adverse Event Report: CAREFUSION 60 IN ULTRA MINIBORE EXTENSION SET; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	ME2017
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Information (3190)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer reported an unspecified failure.The set was inspected for kinks, holes/tears in the tubing, or damages to the components.Visual inspection of the set noted a cut in the tubing approximately 13 inches from the male luer.There were no other anomalies observed.The set's pinch clamp component was inspected.No sharp edges were observed along the component.The pinch clamp was also applied along the tubing.No damage was observed to the tubing.Functional testing confirmed fluid leaking from the cut area.The root cause of the observed damage was not identified.The device history record for model me2017 could not be performed due to no lot number being provided.
Event or Problem Description
The tubing set was received as an unexpected return with an unspecified failure.The customer stated that there is no event information available.

• Brand Name: 60 IN ULTRA MINIBORE EXTENSION SET
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 10367280
• Report Number: 9616066-2020-02307
• Device Sequence Number: 11370850
• Product Code: FPA
• UDI-Device Identifier: 10885403236242
• UDI-Public: 10885403236242
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K051499
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 03/04/2020

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: ME2017
• Device Catalogue Number: ME2017
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/04/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/05/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1