INF SET CLEO 42" 9MM

Report

• Report Number: MW5145058
• Event Type: Malfunction
• Date Received: August 29, 2023
• Report Date: August 27, 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 "NIPPLE ON THE CLEO INSERTION NEEDLE IS MISSING." PATIENT HAD PLACED SITE ON FRIDAY AND THEN NOTICED THAT THIS IS NOW MISSING. SHE STATES THAT THE PUMP IS INFUSING AND SHE HAS THE TUBING CONNECTED WITH NO LEAKAGE. PATIENT SAID THIS HAPPENED ONCE BEFORE (DID NOT SAY WHEN) AND IS FRUSTRATED SHE NEEDS TO PLACE NEW SITE. NO MISSED DOSES OR ADVERSE EVENTS REPORTED. PATIENT HAS DEFECTIVE PRODUCT ON HAND. LOT NUMBER AND EXPIRATION DATE ARE UNKNOWN. NO FURTHER INFORMATION. REPORTED TO CVS/CAREMARK BY: PATIENT/CAREGIVER.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1514948	INF SET CLEO 42" 9MM	SET, ADMINISTRATION, INTRAVASCULAR	FPA	SMITHS MEDICAL ASD INC.

Patients

Seq	Age	Sex	Outcome	Treatment
1		Female

Terms

Patient problem · 1

• No Clinical Signs, Symptoms or Conditions

Type of report · 1

• Initial submission