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

Model Number	30204E
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/19/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Concomitant medical products: bd insyte autoguard shielded iv catheter.The customer¿s report that the tubing ruptured during a reported power injection was confirmed.Visual inspection of the sets tubing area between the smartsite and male luer components to be torn.No other obvious damages or issues were observed.Functional testing was deemed unnecessary due to the obvious damage.The root cause was identified as use related as this is a non pressure-rated set and is not designed for power injector use.
Event or Problem Description
It was reported that during a ct contrast power injection of the patient's abdomen and pelvis, the extension tubing ruptured and leaked.Prior to the ct, an ultrasound-guided iv was placed in right upper arm.There was no patient harm.

• Brand Name: ALARIS EXTENSION SET
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 8997655
• Report Number: 9616066-2019-02557
• Device Sequence Number: 16924943
• Product Code: FPA
• UDI-Device Identifier: 10885403235177
• UDI-Public: 10885403235177
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/20/2019

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 Expiration Date: 04/01/2022
• Device Model Number: 30204E
• Device Catalogue Number: 30204E
• Device Lot Number: 19045033
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/28/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 50