MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. CLEO INFUSION SET; SET, ADMINISTRATION, INTRAVASCULAR

Lot Number 78X033

Device Problems Break (1069); Component Missing (2306)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/01/2019

Event Type  malfunction  

Event Description

Pt reported that 2 times in the past month she has had to change her sq infusion site and the cleo infusion set needle has broken.She stated once it broke and they were able to see it to remove it.The other time they were unable to locate the broken needle and the md was unable to locate the needle via xray.She placed the site yesterday morning; that is still intact.We discussed sending different type/mfr of infusion sets with next upcoming shipment.Pt does have the defective infusion sets in her possession and provided consent for mfr to contact her.Reported to (b)(6) by pt/caregiver.

• Brand Name: CLEO INFUSION SET
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.
• MDR Report Key: 8487562
• MDR Text Key: 141187877
• Report Number: MW5085619
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): Y
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/21/2019
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Lot Number: 78X033
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Patient Age: 55 YR