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

Model Number 30204E

Device Problem Material Rupture (1546)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/19/2019

Event Type  malfunction  

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 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
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• Manufacturer (Section G): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• Manufacturer Contact: ade ajibade ; 10020 pacific mesa blvd; san diego, CA 92121-4386 ; 8586172000
• MDR Report Key: 8997655
• MDR Text Key: 157800448
• Report Number: 9616066-2019-02557
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10885403235177
• UDI-Public: 10885403235177
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K960280
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/11/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 91 YR
• Patient Weight: 50