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

Model Number 10014881

Device Problems Obstruction of Flow (2423); Deformation Due to Compressive Stress (2889)

Patient Problem No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

Although requested, no additional information about the patient, medication, or event provided.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 Description

It was reported that the tubing was kinked during a cytoxan infusion resulting in a delay of treatment.

Event Description

It was reported that the tubing was kinked during a cytoxan infusion resulting in a delay of treatment.

Manufacturer Narrative

The customer¿s report of tubing kinked was confirmed.Photo provided by the customer observed tubing kinked near the male luer.The root cause was not identified as no product was returned.Previous investigation have concluded that improper coiling can result in tubing kinks during the packaging manufacturing process.

• Brand Name: ALARIS® SECONDARY ADMINISTRATION SET
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 8905953
• MDR Text Key: 154747963
• Report Number: 9616066-2019-02265
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10885403221934
• UDI-Public: 10885403221934
• Combination Product (y/n): N
• PMA/PMN Number: K944320
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 07/22/2019

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 Model Number: 10014881
• Device Catalogue Number: 10014881
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/19/2019
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 8100,8015,PRI TUBING, THERAPY DATE UNK; 8100,8015,PRI TUBING, THERAPY DATE UNK