FLOWART NEEDLE-FREE SPLIT SEPTUM VALVE

Report

• Report Number: MW5158286
• Event Type: Injury
• Date Received: August 9, 2024
• Report Date: August 6, 2024
• Manufacturer: ASSET MEDIKAL TASARIM SAN. TIC. A.S.
• Product Code: FPA
• Adverse Event: Yes
• Product Problem: Yes
• Report Source: Voluntary report
• Reporter Location: OH, US
• Reporter Occupation: NURSE
• Health Professional: Yes

Narratives

Description of Event or Problem · 0

SIX (6) SEPARATE EVENTS HAVE OCCURRED SINCE MAY 2ND, 2024 WHERE THE DIALYSIS BLOOD LINE BECOMES DISCONNECTED FROM THE FLOWART NEEDLE-FREE SPLIT SEPTUM VALVE WHILE THE PATIENT IS RECEIVING A DIALYSIS TREATMENT. THIS HAS RESULTED IN THE LOSS OF BLOOD ON SEVERAL OF THESE OCCASIONS. THE DISTRIBUTER/MANUFACTURER HAS BEEN NOTIFIED OF EACH EVENT. REFERENCE REPORTS: MW5158284, MW5158285, MW5158287, MW5158288, MW5158289.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
2515249	FLOWART NEEDLE-FREE SPLIT SEPTUM VALVE	SET, ADMINISTRATION, INTRAVASCULAR	FPA	ASSET MEDIKAL TASARIM SAN. TIC. A.S.	(01)08699443580044

Patients

Seq	Age	Sex	Outcome	Treatment
1	NA	Unknown	Required Intervention| O

Terms

Patient problem · 1

• Hemorrhage/Blood Loss/Bleeding

Type of report · 1

• Initial submission