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

Model Number	ME1110
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/07/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Concomitant medical products: pri tubing;8015;8100; td (b)(6) 2020.The devices have been received and the evaluation is pending.A follow up report will be submitted with investigation results once the evaluation has been completed.
Event or Problem Description
Received a copy of the customer's medsun report from fda which states, ¿blood transfusion completed, line disconnected to attach and flush.Hub on blood tubing broke inside of piv luer lock.Luer lock (q site changed) and line was flushed." it was reported from the nicu that after a blood transfusion was completed, the line was disconnected to attach and flush.The hub on the blood tubing was broken inside of the piv luer lock, the luer lock (q site) was change and the line was flushed.There was no patient impact.
Event or Problem Description
Received a copy of the customer's medsun report from fda which states, ¿blood transfusion completed, line disconnected to attach and flush.Hub on blood tubing broke inside of piv luer lock.Luer lock (q site changed) and line was flushed." it was reported from the nicu that after a blood transfusion was completed, the line was disconnected to attach and flush.The hub on the blood tubing was broken inside of the piv luer lock, the luer lock (q site) was change and the line was flushed.There was no patient impact.
Additional Manufacturer Narrative
The customer¿s report that the hub on blood tubing broke was confirmed.Visual inspection observed that the majority of the male luer fixed collar was broken off from the base of the collar.Closer inspection under magnification also observed signs of stress marks at the break site and the broken collar.No other anomalies were observed.Functional testing was not deemed necessary due to the broken male luer fixed collar and the disconnections at the luer that would occur.The root cause was identified as design of the male luer component.

• 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: 10041621
• Report Number: 9616066-2020-01467
• Device Sequence Number: 16585002
• Product Code: FPA
• UDI-Device Identifier: 10885403236044
• UDI-Public: 10885403236044
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K051499
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other,use
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/13/2020

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: ME1110
• Device Catalogue Number: ME1110
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/15/2020
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/10/2020
• Supplement Report FDA Received Date: 08/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: MZ5307,MZ9267,ME1110,TD (B)(6) 2020