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

Model Number	10108964
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Information (3190)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Report source: corporate resource analyst.Although requested, product has not been received.A follow up report will be submitted with failure investigation results should the product be received for evaluation.
Event or Problem Description
It was reported that the extension set is ¿falling apart¿ while in use even when connections are tightened prior to use.The event occurred in the pre-op, pacu.
Additional Manufacturer Narrative
The customer¿s report of tubing falling apart- separated could not be confirmed due to the product was not returned for failure investigation.Although a photo was provided by the customer, the location of the tubing falling apart could not be determined.The root cause was not identified as no product was returned.
Event or Problem Description
It was reported that the extension set is ¿falling apart¿ while in use even when connections are tightened prior to use.The event occurred in the pre-op, pacu.

• Brand Name: ALARIS EXTENSION SET
• Common Device Name: SET, EXTENSION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 8981295
• Report Number: 9616066-2019-02544
• Device Sequence Number: 13544474
• Product Code: FPA
• UDI-Device Identifier: 10885403234149
• UDI-Public: 10885403234149
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K960280
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/15/2019

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 Model Number: 10108964
• Device Catalogue Number: 10108964
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/10/2019
• Supplement Report FDA Received Date: 09/24/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1