MAUDE Adverse Event Report: CAREFUSION ALARIS® PUMP MODULE ADMINISTRATION SET; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	10013186
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/07/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Although requested, the affected product has not been received.A follow up report will be submitted with investigation results should the devices be received for evaluation.
Event or Problem Description
The customer reported that the tubing set was attached to the patient's iv catheter without the use of a needle-free connector.The male luer of the tubing set broke off into the hub of the patient's iv catheter.There was no patient harm.
Additional Manufacturer Narrative
The affected product has been received and the evaluation is pending.A follow up report will be submitted once the evaluation is completed.
Event or Problem Description
The customer reported that the tubing set was attached to the patient's iv catheter without the use of a needle-free connector.The male luer of the tubing set broke off into the hub of the patient's iv catheter.There was no patient harm.
Additional Manufacturer Narrative
The customer¿s report that the male luer of the tubing set broke off was confirmed; however, it was found that it was the male luer of the non-bd set that had broken off.Visual inspection of the connecting non-bd extension set showed that the male luer was broken off.No breaks or damages were found with the bd primary set.The root cause of the break could not be determined.
Event or Problem Description
The customer reported that the tubing set was attached to the patient's iv catheter without the use of a needle-free connector.The male luer of the tubing set broke off into the hub of the patient's iv catheter.There was no patient harm.

• Brand Name: ALARIS® PUMP MODULE ADMINISTRATION SET
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 8001348
• Report Number: 9616066-2018-02002
• Device Sequence Number: 1301982
• Product Code: FPA
• UDI-Device Identifier: 10885403227943
• UDI-Public: 10885403227943
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K944320
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/02/2018

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 Model Number: 10013186
• Device Catalogue Number: 10013186
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/05/2018
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 10/24/2018
• Supplement Report FDA Received Date: 12/07/2018; 01/28/2019
• 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: CENTRAL VENOUS LINE,THERAPY DATE (B)(6) 2018; NON BD EXTENSION SET; CENTRAL VENOUS LINE,THERAPY DATE (B)(6) 2018