INF SET CLEO 24" 6MM

Report

• Report Number: MW5120020
• Event Type: Malfunction
• Date Received: July 24, 2023
• Report Date: July 18, 2023
• Manufacturer: SMITHS MEDICAL ASD, INC.
• Product Code: FPA
• Product Problem: Yes
• Report Source: Voluntary report
• Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL
• Health Professional: Yes

Narratives

Description of Event or Problem · 0

SPONTANEOUS. PATIENT REPORTED THE CLEOS HAVE BEEN MORE DIFFICULT TO REMOVE THE TUBING FROM THE SITE RECENTLY. REPORTED IT SEEMS LIKE THEY ARE STUCK TOGETHER AND EVEN HER HUSBAND HAS A HARD TIME DISCONNECTING THE TUBING FROM THE SITE. NO MISSED DOSE OR ADVERSE EVENT REPORTED DUE TO DEFECTIVE DEVICE. PATIENT DOES NOT HAVE THE DEFECTIVE PRODUCT ON HAND FOR POSSIBLE RETURN. PRODUCT LOT NUMBER AND EXPIRATION DATE ARE UNKNOWN BECAUSE PATIENT THREW AWAY DEFECTIVE DEVICE. NO FURTHER INFORMATION. REPORTED TO (B)(6) BY PT/CAREGIVER.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1635043	INF SET CLEO 24" 6MM	SET, ADMINISTRATION, INTRAVASCULAR	FPA	SMITHS MEDICAL ASD, INC.	21-7220-24

Patients

Seq	Age	Sex	Outcome	Treatment
1		Female

Terms

Patient problem · 1

• No Clinical Signs, Symptoms or Conditions

Type of report · 1

• Initial submission