FDA Adverse Event Malfunction Summary report: N

IV CONNECT INVISION PLUS TOUCH S

MDR report key: 17669907 · Received August 31, 2023

Report

Report Number
MW5145106
Event Type
Malfunction
Date Received
August 31, 2023
Report Date
August 28, 2023
Manufacturer
RYMED TECHNOLOGIES, LLC
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

SPOKE WITH PATIENT'S SPOUSE FOR MONTHLY IV REMODULIN CONSULT. PATIENT IS AT MAINTENANCE. DOSE 55 NKM, 39 ML/24HR PUMP RATE. PATIENT'S SPOUSE SAID THAT THERE HAVE BEEN TWO SEPARATE OCCASIONS WHERE THE PATIENT'S IV INVISION CONNECTORS HAVE DISINTEGRATED AND CAUSED BLOOD TO GET INTO HER CENTRAL LINE. SPOUSE SAYS THAT THE GREEN VALVE PART ON THE BOTTOM IS USUALLY WHERE IT FALLS APART/"DISINTEGRATES" AND HER LINE WILL THEN GET INFILTRATED. SPOUSE SAID THAT BOTH TIMES PATIENT CHANGED THE CONNECTOR AND THE LINE ENDED UP BEING FINE. SPOUSE SAYS THAT THE PATIENT USED A DIFFERENT CONNECTOR WHEN SHE WAS WITH ACCREDO PREVIOUSLY AND LIKED THOSE CONNECTORS BETTER. SPOUSE WAS UNABLE TO PROVIDE ME THE NAME OF THE CONNECTOR. AUTHOR ADVISED THAT WE WILL REACH OUT TO (B)(6)FIELD NURSE [CNSS) TEAM TO SEE IF THEY CAN ASSIST WITH IDENTIFYING THE OTHER CONNECTOR AND SEE IF WE CAN SUPPLY THAT CONNECTOR TO THE PATIENT. PRACTICE "(B)(6)" TO REFILL, MD OFFICE OF THE ABOVE AS WELL. SERIAL NUMBER NOT PROVIDED. PT DID NOT MISS A DOSE OR EXPERIENCED ANY ADVERSE EVENTS DUE TO DEFECTIVE PRODUCT. LOT NUMBER AND EXP DATE ARE UNK. PT DOES NOT HAVE DEFECTIVE PRODUCT ON HAND FOR POSSIBLE RETURN. NO FURTHER INFO. REPORTED TO (B)(6) BY PT/CAREGIVER. REF REPORT: MW5145105.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1870001 IV CONNECT INVISION PLUS TOUCH S SET, ADMINISTRATION, INTRAVASCULAR FPA RYMED TECHNOLOGIES, LLC

Patients

Seq Age Sex Outcome Treatment
1 Female