FDA Adverse Event Other Summary report: N

IV CATHETER

MDR report key: 19476669 · Received June 5, 2024

Report

Report Number
MW5155782
Event Type
Other
Date Received
June 5, 2024
Date of Event
May 22, 2024
Report Date
June 3, 2024
Manufacturer
UNKNOWN
Product Code
LJS
Adverse Event
Yes
Report Source
Voluntary report
Reporter Location
CA, US
Reporter Occupation
PHARMACIST
Health Professional
Yes

Narratives

Description of Event or Problem · 0

CAUSALITY, UNKNOWN. PATIENT INITIALS: (B)(6). DATE OF AWARENESS: 6/3/24. PATIENT REMS ID: (B)(6). PROVIDER REMS ID: (B)(6). REPORTER: PROVIDER. 54 YO FEMALE ON ADEMPAS, OPSUMIT AND REMODULIN FOR PAH. UPON ROUTINE CHART REVIEW, PROVIDER NOTED PATIENT WITH PMH RAYNAUD'S AND SUSPECTED CREST SYNDROME, PULMONARY HTN ON REMODULIN PUMP WHO WAS PRESENTED AT ED ON (B)(6) 2024 FOR VASCULAR CATHETER MALFUNCTION DUE TO BROKEN LUER LOCK. LUER LOCK WAS REPLACED. THE CATHETER IS FLUSHING WITH NO ISSUE. AT TIME OF DISCHARGE, PATIENT WAS ON APPROPRIATE MEDICATIONS WITH RESOLUTION OF PRESENTING SYMPTOMS AND MEDICALLY STABLE FOR DISCHARGE HOME WITH APPROPRIATE FOLLOW UP. PATIENT PRESENTED AT ED AGAIN ON (B)(6) 2024 WITH LEAKING CATHETER. NOTED THAT THE LUER LOCK OF HER VASCULAR CATHETER WAS STUCK IS NOTED TO BE LEAKING. THE LUER LOCK WAS SUCCESSFULLY REMOVED AND REPLACED UPON ARRIVAL TO THE ED. THE PATIENT'S PUMP WAS THEN RECONNECTED NOTED TO HAVE GOOD SIGNAL WITH CONTINUOUS INFUSION. PATIENT WAS DISCHARGED HOME IN STABLE CONDITION. NO CHANGE IN PAH MEDICATIONS NOTED. REFERENCE REPORT MW5155781.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
2320089 IV CATHETER CATHETER, INTRAVASCULAR, THERAPEUTIC, LONG-TERM GREATER THAN 30 DAYS LJS UNKNOWN

Patients

Seq Age Sex Outcome Treatment
1 54 YR Female Other FLONASE.| FUROSEMIDE.| GABAPENTIN.| IMITREX.| METOCLOPRAMIDE.| OMEPRAZOLE.| OPSUMIT.| PAROXETINE.| REMODULIN.| TRAZODONE.| VOLTAREN TOP GEL.